FDA.reportPublic FDA data

Gabapentin

Product NDC
70010-227
11-digit product format
700100227
Labeler code
70010
Product ID
70010-227_3513f676-25fe-02db-e063-6294a90a1f9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA217116
Marketing category
ANDA
Marketing start
2023-06-27
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70010-227-01Gabapentin100 in 1 BOTTLETABLET, FILM COATED1004
70010-227-05Gabapentin500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-227GABAPENTIN TABLET, FILM COATED [GRANULES PHARMACEUTICALS INC.]3Current NDC, 2 package rows20241018_e847bcfa-f3de-404a-8a57-d8a414691e6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNe847bcfa-f3de-404a-8a57-d8a414691e6a4
310434gabapentin 800 MG Oral TabletPSNe847bcfa-f3de-404a-8a57-d8a414691e6a4
310433gabapentin 600 MG Oral TabletSCDe847bcfa-f3de-404a-8a57-d8a414691e6a4
310434gabapentin 800 MG Oral TabletSCDe847bcfa-f3de-404a-8a57-d8a414691e6a4
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 formatDescriptionMarketing startSampleExclude flagStatus
70010-227-0170010022701100 TABLET, FILM COATED in 1 BOTTLE (70010-227-01) 2023-06-27NoNoCurrent
70010-227-0570010022705500 TABLET, FILM COATED in 1 BOTTLE (70010-227-05) 2023-06-27NoNoCurrent