Doxycycline (Page 4 of 4)

HOW SUPPLIED

Doxycycline Hyclate Capsules, USP are light blue, and imprinted with “186” on the body and “CY” on the cap.

Each capsule contains doxycycline hyclate equivalent to:

100 mg doxycycline

Bottles of 14 (NDC 68788-8588-1)

Bottles of 20 (NDC 68788-8588-2)

Bottles of 28 (NDC 68788-8588-8)

Bottles of 30 (NDC 68788-8588-3)

Bottles of 60 (NDC 68788-8588-6)

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.

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.

Manufactured by:

Changzhou Pharmaceutical Factory

No. 518 Laodong East Road,

Changzhou, Jiangsu, 213018, China

Distributed by:

Tris Pharma, Inc.

Monmouth Junction, NJ 08852 USA

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LB8652

Rev. 00

Revised 06/2021

Repackaged By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL

NDC 68788-5888

Doxycycline Hyclate Capsules, USP

100 mg*

Rx only

Doxycycline Hyclate Capsules USP 100mg
(click image for full-size original)
DOXYCYCLINE
doxycycline capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-8588(NDC:27808-233)
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
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POTASSIUM HYDROXIDE
SHELLAC
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERRIC OXIDE RED
Product Characteristics
Color blue (light blue) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code 186;CY
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-8588-1 14 CAPSULE in 1 BOTTLE None
2 NDC:68788-8588-2 20 CAPSULE in 1 BOTTLE None
3 NDC:68788-8588-8 28 CAPSULE in 1 BOTTLE None
4 NDC:68788-8588-3 30 CAPSULE in 1 BOTTLE None
5 NDC:68788-8588-6 60 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209402 02/20/2024
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-8588)

Revised: 02/2024 Preferred Pharmaceuticals Inc.

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