Doxycycline Hyclate (Page 4 of 4)

HOW SUPPLIED

Doxycycline Hyclate Tablets, USP 100 mg are orange color coated, round, biconvex tablets, debossed with “n” above and “794” below on one side and plain on other side.

Bottles of 20 tablets

NDC 40032-794-02

Bottles of 50 tablets

NDC 40032-794-50

Bottles of 100 tablets

NDC 40032-794-01

Bottles of 500 tablets

NDC 40032-794-05

Bottles of 1000 tablets

NDC 40032-794-10

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

ANIMAL PHARMACOLOGY AND OR 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

1. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Sixth Informational Supplement, CLSI document M100-S26 [2016], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087.
2. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard -Tenth Edition. CLSI document M07-A10[2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Twelfth Edition CLSI document M02-A12 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
4. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline – Third Edition CLSI document M45-A3 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
5. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard -Eighth Edition. CLSI document M11-A8 [2012]. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA.
6. Clinical and Laboratory Standards Institute. Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard—Second Edition. CLSI document M24-A2 [2011]. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA.
7. Clinical and Laboratory Standards Institute. Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline. CLSI document M43-A [2011]. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA.
8. Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press, 2000: 149–195.
9. Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997; 89: 524–528.
10. Horne HW Jr and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25: 315–317.
11. Hale T. Medications and Mothers Milk. 9th edition. Amarillo, TX: Pharmasoft Publishing, 2000: 225–226.

Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873

PI7940000105

Rev. 03/2018

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Doxycycline Hyclate Tablets 100 mg- 20 count

Image

Doxycycline Hyclate Tablets 100 mg- 1000 count

DOXYCYCLINE HYCLATE doxycycline hyclate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-794 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 SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM DOCUSATE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE ALCOHOL HYPROMELLOSE 2910 (10000 MPA.S) POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE FD&C BLUE NO. 2 FD&C YELLOW NO. 6

Product Characteristics Color ORANGE Score no score Shape ROUND (biconvex) Size 9mm Flavor Imprint Code n;794 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:40032-794-50 50 TABLET in 1 BOTTLE None 2 NDC:40032-794-05 500 TABLET in 1 BOTTLE None 3 NDC:40032-794-01 100 TABLET in 1 BOTTLE None 4 NDC:40032-794-02 20 TABLET in 1 BOTTLE None 5 NDC:40032-794-10 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207558 09/06/2017

Labeler — Novel Laboratories, Inc. (793518643)

Registrant — Novel Laboratories, Inc. (793518643)

Establishment
Name	Address	ID/FEI	Operations
Novel Laboratories, Inc.		793518643	ANALYSIS (40032-794), MANUFACTURE (40032-794), PACK (40032-794)

Revised: 03/2018 Novel Laboratories, Inc.