Doxycycline Hyclate (Page 4 of 4)

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.

Distributed by:

PuraCap Laboratories, LLC

DBA Blu Pharmaceuticals

Laurelton, NY 11413

Rev. 08-2020-00

MF312BLUREV08/20

BP0065-09

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 mg 500 Tablets

100mg-500ct.jpg
(click image for full-size original)
DOXYCYCLINE HYCLATE
doxycycline hyclate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24658-312
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
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
POLYSORBATE 80
FD&C BLUE NO. 2
Product Characteristics
Color BROWN (BEIGE) Score no score
Shape ROUND (convex) Size 9mm
Flavor Imprint Code 312;B
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24658-312-20 20 TABLET in 1 BOTTLE None
2 NDC:24658-312-50 50 TABLET in 1 BOTTLE None
3 NDC:24658-312-01 100 TABLET in 1 BOTTLE None
4 NDC:24658-312-05 500 TABLET in 1 BOTTLE None
5 NDC:24658-312-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062269 11/25/2013
Labeler — PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS (080210964)
Registrant — Caribe Holdings (Cayman) Co. Ltd. dba PuraCap Caribe (080230346)
Establishment
Name Address ID/FEI Operations
Caribe Holdings (Cayman) Co. Ltd. dba PuraCap Caribe 080230346 MANUFACTURE (24658-312)

Revised: 04/2022 PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS

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