FDA.reportPublic FDA data

Gabapentin

Product NDC
71093-111
11-digit product format
710930111
Labeler code
71093
Product ID
71093-111_c5f1ec3b-405e-4128-882b-43559d5083e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ACI Healthcare USA, Inc.
Application
ANDA203244
Marketing category
ANDA
Marketing start
2014-01-11
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71093-111-04Gabapentin100 in 1 BOTTLETABLET, FILM COATED10017
71093-111-05Gabapentin500 in 1 BOTTLETABLET, FILM COATED50017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71093-111-04EA - Each71093-11142ed8818-570a-4f32-8836-a6f611483ed912017-07-07
71093-111-05EA - Each71093-111e958a0dd-6f2f-45f6-854d-15808cae696612017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [DIRECT RX]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGABAPENTIN TABLET [DIRECT RX]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PGABAPENTIN TABLET [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [DIRECT RX]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN TABLET [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [DIRECT RX]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71093-111GABAPENTIN TABLET, FILM COATED [ACI HEALTHCARE USA, INC.]17Current NDC, Legacy NDC, 2 package rows20231218_d7646d5e-ca25-4ec5-9e4b-931edcb15a0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN6e6b9d8f-9f9e-4760-96ea-fb8b0a3bbbdb104
310433gabapentin 600 MG Oral TabletSCD6e6b9d8f-9f9e-4760-96ea-fb8b0a3bbbdb104
310433gabapentin 600 MG Oral TabletPSNc9944562-563a-423d-972c-f0313375d234102
310433gabapentin 600 MG Oral TabletSCDc9944562-563a-423d-972c-f0313375d234102
310433gabapentin 600 MG Oral TabletPSN0eb27e64-1488-4083-82c7-cebb8c0605de101
310433gabapentin 600 MG Oral TabletSCD0eb27e64-1488-4083-82c7-cebb8c0605de101
310433gabapentin 600 MG Oral TabletPSNd7646d5e-ca25-4ec5-9e4b-931edcb15a0e17
310434gabapentin 800 MG Oral TabletPSNd7646d5e-ca25-4ec5-9e4b-931edcb15a0e17
310433gabapentin 600 MG Oral TabletSCDd7646d5e-ca25-4ec5-9e4b-931edcb15a0e17
310434gabapentin 800 MG Oral TabletSCDd7646d5e-ca25-4ec5-9e4b-931edcb15a0e17
310433gabapentin 600 MG Oral TabletPSN07c8bb17-9bd4-4fab-994d-0412205b53b414
310433gabapentin 600 MG Oral TabletSCD07c8bb17-9bd4-4fab-994d-0412205b53b414
310433gabapentin 600 MG Oral TabletPSN01aafb0d-6cf4-406d-baad-560a6c91b33f7
310433gabapentin 600 MG Oral TabletSCD01aafb0d-6cf4-406d-baad-560a6c91b33f7
310433gabapentin 600 MG Oral TabletPSN7d3fc163-25f0-2c61-e053-2991aa0a76e96
310433gabapentin 600 MG Oral TabletSCD7d3fc163-25f0-2c61-e053-2991aa0a76e96
310433gabapentin 600 MG Oral TabletPSN39149f0e-30ed-4671-8be7-2a484f65d63b3
310433gabapentin 600 MG Oral TabletSCD39149f0e-30ed-4671-8be7-2a484f65d63b3
310433gabapentin 600 MG Oral TabletPSNa8539169-25fc-79e7-e053-2995a90a69251
310433gabapentin 600 MG Oral TabletPSNb2757fb9-1776-f115-e053-2995a90acddf1
310433gabapentin 600 MG Oral TabletPSN8b2f38ef-0a0c-45cc-88ca-cc086bf806411
310434gabapentin 800 MG Oral TabletPSNa8539169-25fc-79e7-e053-2995a90a69251
310433gabapentin 600 MG Oral TabletSCDa8539169-25fc-79e7-e053-2995a90a69251
310433gabapentin 600 MG Oral TabletSCDb2757fb9-1776-f115-e053-2995a90acddf1
310433gabapentin 600 MG Oral TabletSCD8b2f38ef-0a0c-45cc-88ca-cc086bf806411
310434gabapentin 800 MG Oral TabletSCDa8539169-25fc-79e7-e053-2995a90a69251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71093-111-0471093011104100 TABLET, FILM COATED in 1 BOTTLE (71093-111-04) 2014-01-110000-00-00NoNoCurrent
71093-111-0571093011105500 TABLET, FILM COATED in 1 BOTTLE (71093-111-05) 2014-01-110000-00-00NoNoCurrent