FDA.reportPublic FDA data

Gabapentin

Product NDC
70518-3330
11-digit product format
705183330
Labeler code
70518
Product ID
70518-3330_50360d3c-a26e-02e3-e063-6394a90a7f3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090858
Marketing category
ANDA
Marketing start
2022-01-11
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430

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
70518-3330-0Gabapentin100 in 1 BOXCAPSULE1007
70518-3330-1Gabapentin1 in 1 POUCHCAPSULE17
70518-3330-2Gabapentin180 in 1 BOTTLE, PLASTICCAPSULE1807
70518-3330-3Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1007
70518-3330-4Gabapentin50 in 1 BOXCAPSULE507

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNfce0c123-29d7-42bf-8c8d-8be1772e2d997
310430gabapentin 100 MG Oral CapsuleSCDfce0c123-29d7-42bf-8c8d-8be1772e2d997

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3330-070518333000100 POUCH in 1 BOX (70518-3330-0) > 1 CAPSULE in 1 POUCH (70518-3330-1) 100 pouch2022-01-110000-00-00NoNoCurrent
70518-3330-1705183330011 in 1 POUCHHistorical
70518-3330-270518333002180 CAPSULE in 1 BOTTLE, PLASTIC (70518-3330-2) 180 capsule2025-07-25NoNoHistorical
70518-3330-370518333003100 CAPSULE in 1 BOTTLE, PLASTIC (70518-3330-3) 100 capsule2025-12-22NoNoHistorical
70518-3330-47051833300450 POUCH in 1 BOX (70518-3330-4) / 1 CAPSULE in 1 POUCH (70518-3330-1) 50 pouch2026-04-24NoNoHistorical