Gabapentin

Product NDC
70518-4532
11-digit product format
705184532
Labeler code
70518
Product ID
70518-4532_4585827a-6779-2709-e063-6294a90a6830
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA217116
Marketing category
ANDA
Marketing start
2025-12-07
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

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
70518-4532-0Gabapentin100 in 1 BOXTABLET, FILM COATED1001
70518-4532-1Gabapentin1 in 1 POUCHTABLET, FILM COATED11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNfb726cb0-d422-48dd-a8ed-adbde812b0051
310433gabapentin 600 MG Oral TabletSCDfb726cb0-d422-48dd-a8ed-adbde812b0051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4532-070518453200100 POUCH in 1 BOX (70518-4532-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4532-1) 100 pouch2025-12-07NoNoCurrent
70518-4532-1705184532011 in 1 POUCHHistorical