Doxycycline Hyclate (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Label

NDC 51862-709-12

Doxycycline Hyclate
Delayed-Release
Tablets, USP

Do not chew or crush tablets.

Each tablet contains specially coated pellets
of doxycycline hyclate equivalent to 50 mg of doxycycline.

50 mg

Rx Only

120 Tablets

mayne pharma

PRINCIPAL DISPLAY PANEL -- 50 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 80 mg Tablet Bottle Label

NDC 51862-571-30

Doxycycline Hyclate
Delayed-Release Tablets, USP

Do not chew or crush tablets.
Each tablet contains specially coated pellets of doxycycline
hyclate equivalent to 80 mg of doxycycline.

80 mg

Rx Only 30 Tablets

mayne pharma

PRINCIPAL DISPLAY PANEL -- 80 mg Tablet Bottle Label
(click image for full-size original)
DOXYCYCLINE HYCLATE doxycycline hyclate tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51862-709
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Doxycycline Hyclate (Doxycycline Anhydrous) Doxycycline Anhydrous 50 mg
Inactive Ingredients
Ingredient Name Strength
Lactose Monohydrate
Sodium Lauryl Sulfate
Sodium Chloride
Talc
Anhydrous Lactose
Starch, Corn
CROSPOVIDONE (120 .MU.M)
Magnesium Stearate
Microcrystalline Cellulose
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
TRIETHYL CITRATE
Product Characteristics
Color WHITE (containing yellow pellets) Score no score
Shape OVAL Size 11mm
Flavor Imprint Code D;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51862-709-12 120 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA050795 05/26/2016
DOXYCYCLINE HYCLATE doxycycline hyclate tablet, delayed release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51862-571
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Doxycycline Hyclate (Doxycycline Anhydrous) Doxycycline Anhydrous 80 mg
Inactive Ingredients
Ingredient Name Strength
Sodium Lauryl Sulfate
Sodium Chloride
Talc
Anhydrous Lactose
Starch, Corn
CROSPOVIDONE (120 .MU.M)
Magnesium Stearate
Lactose Monohydrate
Microcrystalline Cellulose
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
TRIETHYL CITRATE
Product Characteristics
Color WHITE (containing yellow pellets) Score 2 pieces
Shape OVAL Size 13mm
Flavor Imprint Code D;8
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51862-571-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA050795 10/02/2020
Labeler — Mayne Pharma (867220261)
Establishment
Name Address ID/FEI Operations
Mayne Pharma International Pty Ltd 756003745 MANUFACTURE (51862-709), MANUFACTURE (51862-571), ANALYSIS (51862-709), ANALYSIS (51862-571), PACK (51862-709), PACK (51862-571), LABEL (51862-709), LABEL (51862-571)
Establishment
Name Address ID/FEI Operations
Mayne Pharma Inc. 867220261 PACK (51862-709), PACK (51862-571), LABEL (51862-709), LABEL (51862-571), ANALYSIS (51862-709), ANALYSIS (51862-571)

Revised: 06/2021 Mayne Pharma

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