Vibramycin Monohydrate (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 100 mg Capsule Bottle Label

Pfizer

NDC 0069-0950-50

Vibramycin ® (doxycycline hyclate)

100 mg*

50 Capsules

Rx only

PRINCIPAL DISPLAY PANEL -- 100 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Label

NDC 0069-0990-50

50 Tablets

Vibra-Tabs ®
(doxycycline hyclate)

100 mg*

Pfizer
Distributed by
Pfizer Labs Division of Pfizer Inc, NY, NY 10017

PRINCIPAL DISPLAY PANEL -- 100 mg Tablet Bottle Label
(click image for full-size original)
VIBRAMYCIN MONOHYDRATE doxycycline powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0970
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 25 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
FD&C BLUE NO. 1
METHYLPARABEN
MICROCRYSTALLINE CELLULOSE
PROPYLPARABEN
D&C RED NO. 28
SUCROSE
Product Characteristics
Color Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-0970-65 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 mL in 1 BOTTLE This package is contained within the CARTON (0069-0970-65)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050006 12/06/1967
VIBRAMYCIN CALCIUM doxycycline calcium syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0971
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE CALCIUM (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 50 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
BUTYLPARABEN
CALCIUM CHLORIDE
GLYCERIN
HYDROCHLORIC ACID
MAGNESIUM ALUMINUM SILICATE
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
PROPYLPARABEN
SODIUM HYDROXIDE
SODIUM METABISULFITE
SORBITOL
WATER
Product Characteristics
Color Score
Shape Size
Flavor RASPBERRY, APPLE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-0971-93 473 mL in 1 BOTTLE None
2 NDC:0069-0971-95 1 BOTTLE in 1 CARTON contains a BOTTLE
2 473 mL in 1 BOTTLE This package is contained within the CARTON (0069-0971-95)
3 NDC:0069-0971-74 1 BOTTLE in 1 CARTON contains a BOTTLE
3 473 mL in 1 BOTTLE This package is contained within the CARTON (0069-0971-74)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050480 09/23/1974
VIBRAMYCIN HYCLATE doxycycline hyclate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0950
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
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM LAURYL SULFATE
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code Vibra;Pfizer;095
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-0950-50 50 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050007 12/05/1967
VIBRA-TABS doxycycline hyclate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0990
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
ETHYLCELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
ALUMINUM OXIDE
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code Vibra;Pfizer;099
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0069-0990-50 50 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050533 01/15/1980 10/01/2010
Labeler — Pfizer Laboratories Div Pfizer Inc (134489525)
Establishment
Name Address ID/FEI Operations
Pharmacia & Upjohn Company LLC 618054084 ANALYSIS (0069-0971), MANUFACTURE (0069-0971), PACK (0069-0971), LABEL (0069-0971)
Establishment
Name Address ID/FEI Operations
Pfizer Ireland Pharmaceuticals 985052076 ANALYSIS (0069-0950), ANALYSIS (0069-0970), ANALYSIS (0069-0971), ANALYSIS (0069-0990), API MANUFACTURE (0069-0950), API MANUFACTURE (0069-0970), API MANUFACTURE (0069-0971), API MANUFACTURE (0069-0990)

Revised: 07/2021 Pfizer Laboratories Div Pfizer Inc

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