FDA.reportPublic FDA data

Gabapentin

Product NDC
71205-932
11-digit product format
712050932
Labeler code
71205
Product ID
71205-932_26bd4975-008b-4029-b0da-3a75b0f7e0f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA205101
Marketing category
ANDA
Marketing start
2016-04-11
Substance
GABAPENTIN
Active strength
800 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433, 310434

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-932-00Gabapentin100 in 1 BOTTLETABLET1004
71205-932-30Gabapentin30 in 1 BOTTLETABLET304
71205-932-55Gabapentin500 in 1 BOTTLETABLET5004
71205-932-60Gabapentin60 in 1 BOTTLETABLET604
71205-932-64Gabapentin240 in 1 BOTTLETABLET2404
71205-932-67Gabapentin270 in 1 BOTTLETABLET2704
71205-932-72Gabapentin120 in 1 BOTTLETABLET1204
71205-932-76Gabapentin360 in 1 BOTTLETABLET3604
71205-932-78Gabapentin180 in 1 BOTTLETABLET1804
71205-932-90Gabapentin90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-932-00EA - Each71205-9326a8568b7-88e9-47a3-9dbf-a3eb6a7d9cb112021-06-02
71205-932-30EA - Each71205-932bdb02b98-3d6e-4627-96c2-8db7b937d5bc12021-06-02
71205-932-55EA - Each71205-932c9cf9463-2bcb-4ead-9b37-6f2f20717dd812021-06-02
71205-932-60EA - Each71205-9322d566046-cbe2-4a9e-b1ee-353e7ab8285b12021-06-02
71205-932-64EA - Each71205-9329f02bb92-00d1-4aad-8a71-b3f93572233012021-06-02
71205-932-67EA - Each71205-932c3a8e5d2-ea27-4028-b18f-7319ffee96a612021-07-15
71205-932-72EA - Each71205-93232d92e9e-50fa-47a5-823b-9d83afd9cce912021-06-02
71205-932-76EA - Each71205-9328503ebd3-a8c2-45ce-901d-06828d20e7cc12021-07-15
71205-932-78EA - Each71205-9329f183599-4411-4cf6-8999-61bbb9ef5e4612021-06-02
71205-932-90EA - Each71205-932217a9e6c-23f8-4b63-b7fb-8b12087dd54712021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-932GABAPENTIN TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 10 package rows20220416_b67b7865-df64-429a-9550-5333b9c713ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNb67b7865-df64-429a-9550-5333b9c713ea4
310434gabapentin 800 MG Oral TabletPSNb67b7865-df64-429a-9550-5333b9c713ea4
310433gabapentin 600 MG Oral TabletSCDb67b7865-df64-429a-9550-5333b9c713ea4
310434gabapentin 800 MG Oral TabletSCDb67b7865-df64-429a-9550-5333b9c713ea4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-932-0071205093200100 TABLET in 1 BOTTLE (71205-932-00) 100 tablet2021-04-220000-00-00NoNoCurrent
71205-932-307120509323030 TABLET in 1 BOTTLE (71205-932-30) 30 tablet2021-04-220000-00-00NoNoCurrent
71205-932-5571205093255500 TABLET in 1 BOTTLE (71205-932-55) 500 tablet2021-04-220000-00-00NoNoCurrent
71205-932-607120509326060 TABLET in 1 BOTTLE (71205-932-60) 60 tablet2021-04-220000-00-00NoNoCurrent
71205-932-6471205093264240 TABLET in 1 BOTTLE (71205-932-64) 240 tablet2021-04-220000-00-00NoNoCurrent
71205-932-6771205093267270 TABLET in 1 BOTTLE (71205-932-67) 270 tablet2021-06-280000-00-00NoNoCurrent
71205-932-7271205093272120 TABLET in 1 BOTTLE (71205-932-72) 120 tablet2021-04-220000-00-00NoNoCurrent
71205-932-7671205093276360 TABLET in 1 BOTTLE (71205-932-76) 360 tablet2021-06-280000-00-00NoNoCurrent
71205-932-7871205093278180 TABLET in 1 BOTTLE (71205-932-78) 180 tablet2021-04-220000-00-00NoNoCurrent
71205-932-907120509329090 TABLET in 1 BOTTLE (71205-932-90) 90 tablet2021-04-220000-00-00NoNoCurrent