GABAPENTIN- gabapentin capsule
DIRECT RX
----------
GABAPENTIN 300mg
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
9 DRUG ABUSE AND DEPENDENCE
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
13 NONCLINICAL TOXICOLOGY
14 CLINICAL STUDIES
16 PATIENT COUNSELING INFORMATION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
GABAPENTIN
gabapentin capsule
Product Information
Product Type
HUMAN PRESCRIPTION DRUG
Item Code (Source)
NDC:61919-839(NDC:45963-556)
Route of Administration
ORAL
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
GABAPENTIN
(UNII: 6CW7F3G59X) (GABAPENTIN - UNII:6CW7F3G59X)
GABAPENTIN
300 mg
Inactive Ingredients
Ingredient Name
Strength
MANNITOL
(UNII: 3OWL53L36A)
FERRIC OXIDE RED
(UNII: 1K09F3G675)
SILICON DIOXIDE
(UNII: ETJ7Z6XBU4)
TALC
(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE
(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW
(UNII: EX438O2MRT)
SHELLAC
(UNII: 46N107B71O)
D&C YELLOW NO. 10
(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1
(UNII: H3R47K3TBD)
FD&C RED NO. 40
(UNII: WZB9127XOA)
GELATIN
(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE
(UNII: 368GB5141J)
FERROSOFERRIC OXIDE
(UNII: XM0M87F357)
FD&C BLUE NO. 2
(UNII: L06K8R7DQK)
PROPYLENE GLYCOL
(UNII: 6DC9Q167V3)
STARCH, CORN
(UNII: O8232NY3SJ)
Product Characteristics
Color
brown, yellow
Score
no score
Shape
CAPSULE
Size
19mm
Flavor
Imprint Code
2666
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:61919-839-60
60 in 1 BOTTLE; Type 0: Not a Combination Product
03/30/2016
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
ANDA
ANDA075350
03/30/2016
Labeler -
DIRECT RX (079254320)
Establishment
Name
Address
ID/FEI
Business Operations
DIRECT RX
079254320
repack(61919-839)
Revised: 3/2016
Document Id:
2f5ac7c6-a927-57df-e054-00144ff8d46c
Set id: 2f5ac7c6-a926-57df-e054-00144ff8d46c
Version: 1
Effective Time: 20160331
DIRECT RX
