Doxycycline Hyclate (Page 5 of 5)

HOW SUPPLIED

Doxycycline Hyclate Capsules, USP 100 mg are available as a light blue capsule filled with yellow powder imprinted with “2985” containing Doxycycline Hyclate, equivalent to 100 mg of doxycycline. They are supplied as follows:

NDC 12634-169-00 Bottles of 10

NDC 12634-169-01 Bottles of 100

NDC 12634-169-09 Bottles of 35

NDC 12634-169-12 Bottles of 120

NDC 12634-169-18 Bottles of 180

NDC 12634-169-40 Bottles of 40

NDC 12634-169-42 Bottles of 42

NDC 12634-169-45 Bottles of 45

NDC 12634-169-50 Bottles of 50

NDC 12634-169-52 Blister Pack of 12

NDC 12634-169-54 Blister Pack of 14

NDC 12634-169-57 Blister Pack of 20

NDC 12634-169-59 Blister Pack of 30

NDC 12634-169-60 Bottles of 60

NDC 12634-169-61 Blister Pack of 10

NDC 12634-169-63 Blister Pack of 3

NDC 12634-169-66 Blister Pack of 6

NDC 12634-169-67 Blister Pack of 7

NDC 12634-169-69 Blister Pack of 9

NDC 12634-169-71 Bottles of 30

NDC 12634-169-74 Bottles of 24

NDC 12634-169-78 Bottles of 28

NDC 12634-169-79 Bottles of 25

NDC 12634-169-80 Bottles of 20

NDC 12634-169-81 Bottles of 21

NDC 12634-169-82 Bottles of 12

NDC 12634-169-84 Bottles of 14

NDC 12634-169-85 Bottles of 15

NDC 12634-169-90 Bottles of 90

NDC 12634-169-91 Blister Pack of 1

NDC 12634-169-92 Bottles of 2

NDC 12634-169-93 Bottles of 3

NDC 12634-169-94 Bottles of 4

NDC 12634-169-95 Bottles of 5

NDC 12634-169-96 Bottles of 6

NDC 12634-169-97 Bottles of 7

NDC 12634-169-98 Bottles of 8

NDC 12634-169-99 Bottles of 9

Dispense in a tight, light resistant container as defined in the USP, with a child resistant closure (as required).

Store at 20° to 25° C (68° to 77° F) (see USP controlled room temperature)

ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY

Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO4, and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO4, and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.

Minocycline, tetracycline PO4, methacycline, doxycycline, tetracycline base, oxytetracycline HCl, and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.

Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline); in chickens (chlortetracycline); and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.

REFERENCES

  • Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement , CLSI document M100-S24. CLSI document M100-S24, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2014.
  • Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard — Ninth Edition. CLSI document M07- A9, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
  • Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Eleventh Edition. CLSI document M02-A11, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
  • Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline -Second Edition. CLSI document M45-A2, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2010.
  • Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard — Eighth Edition. CLSI document M11-A8. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA, 2012.
  • Clinical and Laboratory Standards Institute. Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard—Second Edition. CLSI document M24- A2. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA, 2011.
  • Clinical and Laboratory Standards Institute. Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline. CLSI document M43-A. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA, 2011.
  • Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press, 2000: 149-195.
  • Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997; 89: 524-528.
  • Horne HW Jr and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25: 315-317.
  • Hale T. Medications and Mothers Milk. 9 th edition. Amarillo, TX: Pharmasoft Publishing, 2000: 225-226.

Manufactured for:

Cipla USA, Inc.
9100 S. Dadeland Blvd.
Suite 1500 Miami, FL 33156

Made in USA

Rev. 01 10/2014

Repackaged & Distributed by:

Apotheca Inc.

Phoenix, AZ 85006

PRINCIPAL DISPLAY PANEL — 100 mg Capsule Bottle Label

NDC 12634-169-80
Rx ONLY

Doxycycline
Hyclate Capsules USP

100 mg*

20 Capsules

label
(click image for full-size original)
DOXYCYCLINE HYCLATE doxycycline hyclate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:12634-169(NDC:69097-226)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 100 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
STEARIC ACID
TITANIUM DIOXIDE
FD&C BLUE NO. 1
SODIUM STARCH GLYCOLATE TYPE A POTATO
METHYLCELLULOSE (400 MPA.S)
Product Characteristics
Color blue (light blue) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code 2985
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:12634-169-00 10 CAPSULE in 1 BOTTLE None
2 NDC:12634-169-01 100 CAPSULE in 1 BOTTLE None
3 NDC:12634-169-09 35 CAPSULE in 1 BOTTLE None
4 NDC:12634-169-12 120 CAPSULE in 1 BOTTLE None
5 NDC:12634-169-18 180 CAPSULE in 1 BOTTLE None
6 NDC:12634-169-40 40 CAPSULE in 1 BOTTLE None
7 NDC:12634-169-42 42 CAPSULE in 1 BOTTLE None
8 NDC:12634-169-45 45 CAPSULE in 1 BOTTLE None
9 NDC:12634-169-50 50 CAPSULE in 1 BOTTLE None
10 NDC:12634-169-52 12 CAPSULE in 1 BLISTER PACK None
11 NDC:12634-169-54 14 CAPSULE in 1 BLISTER PACK None
12 NDC:12634-169-57 20 CAPSULE in 1 BLISTER PACK None
13 NDC:12634-169-59 30 CAPSULE in 1 BLISTER PACK None
14 NDC:12634-169-60 60 CAPSULE in 1 BOTTLE None
15 NDC:12634-169-61 10 CAPSULE in 1 BLISTER PACK None
16 NDC:12634-169-63 3 CAPSULE in 1 BLISTER PACK None
17 NDC:12634-169-66 6 CAPSULE in 1 BLISTER PACK None
18 NDC:12634-169-67 7 CAPSULE in 1 BLISTER PACK None
19 NDC:12634-169-69 9 CAPSULE in 1 BLISTER PACK None
20 NDC:12634-169-71 30 CAPSULE in 1 BOTTLE None
21 NDC:12634-169-74 24 CAPSULE in 1 BOTTLE None
22 NDC:12634-169-78 28 CAPSULE in 1 BOTTLE None
23 NDC:12634-169-79 25 CAPSULE in 1 BOTTLE None
24 NDC:12634-169-80 20 CAPSULE in 1 BOTTLE None
25 NDC:12634-169-81 21 CAPSULE in 1 BOTTLE None
26 NDC:12634-169-82 12 CAPSULE in 1 BOTTLE None
27 NDC:12634-169-84 14 CAPSULE in 1 BOTTLE None
28 NDC:12634-169-85 15 CAPSULE in 1 BOTTLE None
29 NDC:12634-169-90 90 CAPSULE in 1 BOTTLE None
30 NDC:12634-169-91 1 CAPSULE in 1 BLISTER PACK None
31 NDC:12634-169-92 2 CAPSULE in 1 BOTTLE None
32 NDC:12634-169-93 3 CAPSULE in 1 BOTTLE None
33 NDC:12634-169-94 4 CAPSULE in 1 BOTTLE None
34 NDC:12634-169-95 5 CAPSULE in 1 BOTTLE None
35 NDC:12634-169-96 6 CAPSULE in 1 BOTTLE None
36 NDC:12634-169-97 7 CAPSULE in 1 BOTTLE None
37 NDC:12634-169-98 8 CAPSULE in 1 BOTTLE None
38 NDC:12634-169-99 9 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062500 09/11/1984
Labeler — Apotheca Inc. (051457844)
Establishment
Name Address ID/FEI Operations
Apotheca Inc. 051457844 relabel (12634-169), repack (12634-169)

Revised: 01/2017 Apotheca Inc.

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