Gabapentin

Product NDC
70518-3329
11-digit product format
705183329
Labeler code
70518
Product ID
70518-3329_50362117-efb7-1c17-e063-6394a90a021f
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
300 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
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310431

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
70518-3329-0Gabapentin100 in 1 BOXCAPSULE10011
70518-3329-1Gabapentin1 in 1 POUCHCAPSULE111
70518-3329-2Gabapentin270 in 1 BOTTLE, PLASTICCAPSULE27011
70518-3329-3Gabapentin14 in 1 BOTTLE, PLASTICCAPSULE1411
70518-3329-4Gabapentin100 in 1 BOXCAPSULE10011
70518-3329-5Gabapentin1 in 1 POUCHCAPSULE111
70518-3329-6Gabapentin50 in 1 BOXCAPSULE5011
70518-3329-7Gabapentin1 in 1 POUCHCAPSULE111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3329GABAPENTIN CAPSULE [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 8 package rows20241003_ddb3a54f-5224-4024-8804-b2a2f01d885e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNddb3a54f-5224-4024-8804-b2a2f01d885e11
310431gabapentin 300 MG Oral CapsuleSCDddb3a54f-5224-4024-8804-b2a2f01d885e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3329-070518332900100 POUCH in 1 BOX (70518-3329-0) / 1 CAPSULE in 1 POUCH (70518-3329-1) 100 pouch2022-01-110000-00-00NoNoCurrent
70518-3329-1705183329011 in 1 POUCHHistorical
70518-3329-270518332902270 CAPSULE in 1 BOTTLE, PLASTIC (70518-3329-2) 270 capsule2022-01-260000-00-00NoNoCurrent
70518-3329-37051833290314 in 1 BOTTLE, PLASTICHistorical
70518-3329-470518332904100 POUCH in 1 BOX (70518-3329-4) / 1 CAPSULE in 1 POUCH (70518-3329-5) 100 pouch2024-07-17NoNoHistorical
70518-3329-5705183329051 in 1 POUCHHistorical
70518-3329-67051833290650 POUCH in 1 BOX (70518-3329-6) / 1 CAPSULE in 1 POUCH (70518-3329-7) 50 pouch2026-04-24NoNoHistorical
70518-3329-7705183329071 in 1 POUCHHistorical