FDA.reportPublic FDA data

Gabapentin

Product NDC
71205-931
11-digit product format
712050931
Labeler code
71205
Product ID
71205-931_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
600 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
GABAPENTIN600 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
71205-931-00Gabapentin100 in 1 BOTTLETABLET1004
71205-931-30Gabapentin30 in 1 BOTTLETABLET304
71205-931-55Gabapentin500 in 1 BOTTLETABLET5004
71205-931-60Gabapentin60 in 1 BOTTLETABLET604
71205-931-64Gabapentin240 in 1 BOTTLETABLET2404
71205-931-67Gabapentin270 in 1 BOTTLETABLET2704
71205-931-72Gabapentin120 in 1 BOTTLETABLET1204
71205-931-76Gabapentin360 in 1 BOTTLETABLET3604
71205-931-78Gabapentin180 in 1 BOTTLETABLET1804
71205-931-90Gabapentin90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-931-00EA - Each71205-931ffee957d-af86-47d5-ac8f-99c7e733611312021-06-02
71205-931-30EA - Each71205-9318b9a6d42-f495-4771-a05b-a853e0aa5a3d12021-06-02
71205-931-55EA - Each71205-93155415c3e-a4f0-4b6e-be2f-9ab53e990bc112021-06-02
71205-931-60EA - Each71205-93193754f76-b16c-4e8f-827a-ee6f661baeb512021-06-02
71205-931-64EA - Each71205-9318ffac12f-730f-4302-8544-a3737f44f20612021-06-02
71205-931-67EA - Each71205-9317964d9d4-de74-4370-8572-70242cca55db12021-07-15
71205-931-72EA - Each71205-9313368af03-ddef-4b6e-bd54-16660762fee912021-06-02
71205-931-76EA - Each71205-93137581a7f-c812-4d32-9b89-88f53b8c7f8312021-07-15
71205-931-78EA - Each71205-93149248931-a982-45d4-9c8e-7476b85922ca12021-06-02
71205-931-90EA - Each71205-931d2d8e219-f8ac-4ebd-b2c3-3128b9f4246312021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-931GABAPENTIN 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
71205-931-0071205093100100 TABLET in 1 BOTTLE (71205-931-00) 100 tablet2021-04-220000-00-00NoNoCurrent
71205-931-307120509313030 TABLET in 1 BOTTLE (71205-931-30) 30 tablet2021-04-220000-00-00NoNoCurrent
71205-931-5571205093155500 TABLET in 1 BOTTLE (71205-931-55) 500 tablet2021-04-220000-00-00NoNoCurrent
71205-931-607120509316060 TABLET in 1 BOTTLE (71205-931-60) 60 tablet2021-04-220000-00-00NoNoCurrent
71205-931-6471205093164240 TABLET in 1 BOTTLE (71205-931-64) 240 tablet2021-04-220000-00-00NoNoCurrent
71205-931-6771205093167270 TABLET in 1 BOTTLE (71205-931-67) 270 tablet2021-06-280000-00-00NoNoCurrent
71205-931-7271205093172120 TABLET in 1 BOTTLE (71205-931-72) 120 tablet2021-04-220000-00-00NoNoCurrent
71205-931-7671205093176360 TABLET in 1 BOTTLE (71205-931-76) 360 tablet2021-06-280000-00-00NoNoCurrent
71205-931-7871205093178180 TABLET in 1 BOTTLE (71205-931-78) 180 tablet2021-04-220000-00-00NoNoCurrent
71205-931-907120509319090 TABLET in 1 BOTTLE (71205-931-90) 90 tablet2021-04-220000-00-00NoNoCurrent