Phendimetrazine Tartrate (Page 3 of 3)

Phendimetrazine 105mg Capsule(CIII)

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PHENDIMETRAZINE TARTRATE
phendimetrazine tartrate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-3051(NDC:0185-5254)
Route of Administration ORAL DEA Schedule CIII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENDIMETRAZINE TARTRATE (PHENDIMETRAZINE) PHENDIMETRAZINE TARTRATE 105 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
FD&C RED NO. 40
GELATIN, UNSPECIFIED
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STARCH, CORN
SUCROSE
TALC
SHELLAC
Product Characteristics
Color BROWN (Brown/Clear) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code E5254
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-3051-1 28 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
2 NDC:63629-3051-2 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
3 NDC:63629-3051-6 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
4 NDC:63629-3051-7 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
5 NDC:63629-3051-5 2 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
6 NDC:63629-3051-3 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
7 NDC:63629-3051-4 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
8 NDC:63629-3051-8 21 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
9 NDC:63629-3051-9 45 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018074 09/06/1977
Labeler — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-3051), RELABEL (63629-3051)

Revised: 10/2020 Bryant Ranch Prepack

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