Gabapentin

Product NDC
71093-112
11-digit product format
710930112
Labeler code
71093
Product ID
71093-112_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
800 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
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
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
71093-112-04Gabapentin100 in 1 BOTTLETABLET, FILM COATED10017
71093-112-05Gabapentin500 in 1 BOTTLETABLET, FILM COATED50017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71093-112-04EA - Each71093-112cce35ccf-60b6-4a3b-a93e-75307f6ef78312017-07-07
71093-112-05EA - Each71093-112094e08bc-edc2-4b72-95d6-1000ce7fc09112017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71093-112GABAPENTIN 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
310434gabapentin 800 MG Oral TabletPSN56967a93-b3c0-4043-9241-585fc64e2624101
310434gabapentin 800 MG Oral TabletSCD56967a93-b3c0-4043-9241-585fc64e2624101
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
310430gabapentin 100 MG Oral CapsulePSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310432gabapentin 400 MG Oral CapsulePSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletPSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310430gabapentin 100 MG Oral CapsuleSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310432gabapentin 400 MG Oral CapsuleSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletPSN47f2a06f-4eac-4dca-aa2a-a36dd4daaea07
310434gabapentin 800 MG Oral TabletSCD47f2a06f-4eac-4dca-aa2a-a36dd4daaea07
310434gabapentin 800 MG Oral TabletPSNb4954172-5439-48fd-8348-8a2e0d2fee625
310434gabapentin 800 MG Oral TabletSCDb4954172-5439-48fd-8348-8a2e0d2fee625
310434gabapentin 800 MG Oral TabletPSNc09c66fd-cb31-41dd-b00b-acc58bd809f73
310434gabapentin 800 MG Oral TabletSCDc09c66fd-cb31-41dd-b00b-acc58bd809f73
310434gabapentin 800 MG Oral TabletPSNb6db5ce9-bd4b-420d-88a7-df9d46144c812
310434gabapentin 800 MG Oral TabletSCDb6db5ce9-bd4b-420d-88a7-df9d46144c812
310433gabapentin 600 MG Oral TabletPSNa8539169-25fc-79e7-e053-2995a90a69251
310434gabapentin 800 MG Oral TabletPSNba2a8352-5776-4edb-914e-ce1d18ccda321
310434gabapentin 800 MG Oral TabletPSNa8539169-25fc-79e7-e053-2995a90a69251
310434gabapentin 800 MG Oral TabletPSN9af351e3-1a98-7523-e053-2a95a90a9ca91
310433gabapentin 600 MG Oral TabletSCDa8539169-25fc-79e7-e053-2995a90a69251
310434gabapentin 800 MG Oral TabletSCDa8539169-25fc-79e7-e053-2995a90a69251
310434gabapentin 800 MG Oral TabletSCDba2a8352-5776-4edb-914e-ce1d18ccda321
310434gabapentin 800 MG Oral TabletSCD9af351e3-1a98-7523-e053-2a95a90a9ca91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71093-112-0471093011204100 TABLET, FILM COATED in 1 BOTTLE (71093-112-04) 2014-01-110000-00-00NoNoCurrent
71093-112-0571093011205500 TABLET, FILM COATED in 1 BOTTLE (71093-112-05) 2014-01-110000-00-00NoNoCurrent