SUMATRIPTAN - sumatriptan succinate tablet

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO)
Available from:
Bryant Ranch Prepack
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Product summary:
Product: 63629-8134 NDC: 63629-8134-1 9 TABLET in a BOTTLE Product: 63629-8188 NDC: 63629-8188-1 9 TABLET in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
63629-8134-1, 63629-8188-1

Bryant Ranch Prepack

----------

Sumatriptan Succinate Tablets

Revised: 8/2019

Document Id: d68f0ce2-d6e0-4901-ba43-f33a43186440

34391-3

Set id: a6a4e17a-7841-43cb-b435-e4eb11105a80

Version: 2

Effective Time: 20190807

Bryant Ranch Prepack

SUMATRIPTAN - sumatriptan succinate tablet

Bryant Ranch Prepack

----------

Sumatriptan Succinate Tablets

HOW SUPPLIED

Product: 63629-8134

NDC: 63629-8134-1 9 TABLET in a BOTTLE

Product: 63629-8188

NDC: 63629-8188-1 9 TABLET in a BOTTLE

SUMATRIPTAN 50MG TABLET

SUMATRIPTAN SUCCINATE 100MG TAB

SUMATRIPTAN

sumatriptan succinate tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 36 29 -8 134(NDC:6 58 6 2-147)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SUMATRIPTAN SUCCINATE (UNII: J8 BDZ6 8 9 8 9 ) (SUMATRIPTAN - UNII:8 R78 F6 L9 VO)

SUMATRIPTAN

50 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

ANHYDRO US DIBASIC CALCIUM PHO SPHATE (UNII: L11K75P9 2J)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

Product Characteristics

Color

WHITE (White to o ff-white)

S core

no sco re

S hap e

CAPSULE (bico nvex)

S iz e

11mm

Flavor

Imprint Code

C;33

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 36 29 -8 134-1

9 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/29 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 78 327

0 8 /17/20 0 9

SUMATRIPTAN

sumatriptan succinate tablet

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 36 29 -8 18 8 (NDC:6 58 6 2-148 )

Bryant Ranch Prepack

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SUMATRIPTAN SUCCINATE (UNII: J8 BDZ6 8 9 8 9 ) (SUMATRIPTAN - UNII:8 R78 F6 L9 VO)

SUMATRIPTAN

10 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

ANHYDRO US DIBASIC CALCIUM PHO SPHATE (UNII: L11K75P9 2J)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

Product Characteristics

Color

WHITE (White to o ff-white)

S core

no sco re

S hap e

CAPSULE (bico nvex)

S iz e

12mm

Flavor

Imprint Code

C;34

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 36 29 -8 18 8 -1

9 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 2/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 78 327

0 8 /17/20 0 9

Labeler -

Bryant Ranch Prepack (171714327)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Bryant Ranch Prepack

171714327

REPACK(6 36 29 -8 18 8 , 6 36 29 -8 134) , RELABEL(6 36 29 -8 134, 6 36 29 -8 18 8 )

Revised: 8/2019

Similar products

Search alerts related to this product

View documents history

Share this information