Doxycycline Hyclate (Page 5 of 5)

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. 9 th edition. Amarillo, TX: Pharmasoft Publishing, 2000: 225–226.

Manufactured by:
HIKMA Pharmaceuticals
P.O. Box 182400
Amman 11118 — Jordan

Distr. by:
West- W ard Pharmaceutical s Corp.
Eatontown, NJ 07724 USA

2INDOXY-E
Revised June 2020

PRINCIPAL DISPLAY PANEL

NDC 0143-9803-50
Doxycycline Hyclate Capsules, USP

100 mg

Doxycycline Hyclate Cpsules,100mg-NDC-0143-9803-50
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0143-9802-50
Doxycycline Hyclate Capsules, USP

50 mg

NDC-0143-9802-50-50mg
(click image for full-size original)

PACKAGE LABEL.PRINICPAL DISPLAY PANEL

epm 20 COUNT
(click image for full-size original)

DOXYCYCLINE HYCLATE doxycycline hyclate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-1743(NDC:0143-9803)
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
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
ALCOHOL
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C BLUE NO. 1
D&C YELLOW NO. 10
Product Characteristics
Color blue (Blue/Blue Opaque) Score no score
Shape CAPSULE (CAPSULE) Size 18mm
Flavor Imprint Code Westward;3142
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67296-1743-2 20 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062396 05/07/1984
Labeler — RedPharm Drug, Inc. (828374897)
Establishment
Name Address ID/FEI Operations
EPM Packaging, Inc. 079124340 repack (67296-1743)

Revised: 01/2022 RedPharm Drug, Inc.

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