GABAPENTIN

Product NDC
31722-092
11-digit product format
317220092
Labeler code
31722
Product ID
31722-092_360950f4-eef0-54cb-e063-6394a90aa5d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA218075
Marketing category
ANDA
Marketing start
2024-02-26
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
Rxcui1806380, 1806382

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-092-90GABAPENTIN90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-092-90EA - Each31722-092bc70eb90-2e0f-4f9b-9abb-33baf66ffcea12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-092GABAPENTIN (GABAPENTIN) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]2Current NDC, 1 package rows20250528_0ce53f62-1738-43f4-9a2e-c5dc42a91d09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1806380gabapentin 300 MG Once-Daily Oral TabletPSN0ce53f62-1738-43f4-9a2e-c5dc42a91d092
1806382gabapentin 600 MG Once-Daily Oral TabletPSN0ce53f62-1738-43f4-9a2e-c5dc42a91d092
1806380Once-Daily gabapentin 300 MG Oral TabletSCD0ce53f62-1738-43f4-9a2e-c5dc42a91d092
1806382Once-Daily gabapentin 600 MG Oral TabletSCD0ce53f62-1738-43f4-9a2e-c5dc42a91d092
1806380gabapentin 300 MG Once-Daily Oral TabletSY0ce53f62-1738-43f4-9a2e-c5dc42a91d092
1806382gabapentin 600 MG Once-Daily Oral TabletSY0ce53f62-1738-43f4-9a2e-c5dc42a91d092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-092-903172200929090 TABLET, FILM COATED in 1 BOTTLE (31722-092-90) 2024-02-26NoNoHistorical