DOXYCYCLINE HYCLATE (Page 4 of 4)

HOW SUPPLIED

Doxycycline hyclate tablets USP, are available in yellow colored, round, biconvex film-coated tablets containing doxycycline hyclate equivalent to:

100 mg doxy cy cline

Bottles of 14 (NDC 68788-8464-1

Bottles of 20 (NDC 68788-8464-2

Bottles of 30 (NDC 68788-8464-3

The tablets are imprinted on one side with “CY” and “185” on the other side.

All products are to be Stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and dispensed in tight, light-resistant containers with a child-resistant closure (USP).

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

1. Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press, 2000: 149–195.

2. Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997; 89: 524–528.

3. Horne HW Jr and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25: 315–317.

4. Hale T. Medications and Mothers Milk. 9th edition. Amarillo, TX: Pharmasoft Publishing, 2000: 225–226.

This product’s label may have been updated. For current full prescribing information, please visit www.trispharma.com

Manufactured by:

Changzhou Pharmaceutical Factory

No. 518 Laodong East Road,

Changzhou, Jiangsu, 213018, China

Distributed by:

Tris Pharma, Inc.

Monmouth Junction, NJ 08852 USA

LB8656
Rev. 01Revised November 2021

Repackaged By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Label

NDC 68788-8464

Doxycycline Hyclate Tablets, USP

100 mg*

50 Tablets

Rx only

Doxycycline Hyclate Tablets USP 100mg
(click image for full-size original)
DOXYCYCLINE HYCLATE doxycycline hyclate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-8464(NDC:27808-234)
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
CROSCARMELLOSE SODIUM
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
TITANIUM DIOXIDE
WATER
Product Characteristics
Color yellow Score no score
Shape ROUND Size 9mm
Flavor Imprint Code CY;185
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-8464-1 14 TABLET in 1 BOTTLE None
2 NDC:68788-8464-2 20 TABLET in 1 BOTTLE None
3 NDC:68788-8464-3 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211343 06/23/2023
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-8464)

Revised: 06/2023 Preferred Pharmaceuticals Inc.

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