FDA.reportPublic FDA data

GABAPENTIN

Product NDC
31722-166
11-digit product format
317220166
Labeler code
31722
Product ID
31722-166_8796e28d-fb63-4438-bec3-aac2dd9decf5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA214957
Marketing category
ANDA
Marketing start
2021-10-01
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-166-01GABAPENTIN100 in 1 BOTTLETABLET1003
31722-166-05GABAPENTIN500 in 1 BOTTLETABLET5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-166-01EA - Each31722-16646646a82-56aa-4816-b985-d5a576ba937112021-12-08
31722-166-05EA - Each31722-1668ac374ae-eadf-4af9-bac5-9d732bc6571b12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-166GABAPENTIN TABLET [CAMBER PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20241012_9ead7825-d11b-4e00-8533-328d097b8f83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNfbc05ceb-2e69-3c37-e053-6394a90ac4f44
310433gabapentin 600 MG Oral TabletPSN35da078b-0da0-4757-a6c4-a9144c37e8e14
310433gabapentin 600 MG Oral TabletPSN38119f2e-33b3-4c3c-99b7-9335d8d280d44
310433gabapentin 600 MG Oral TabletSCDfbc05ceb-2e69-3c37-e053-6394a90ac4f44
310433gabapentin 600 MG Oral TabletSCD35da078b-0da0-4757-a6c4-a9144c37e8e14
310433gabapentin 600 MG Oral TabletSCD38119f2e-33b3-4c3c-99b7-9335d8d280d44
310433gabapentin 600 MG Oral TabletPSN10424d11-fca8-4825-8450-96d9a91908193
310433gabapentin 600 MG Oral TabletPSNfebf610e-e088-4797-e053-6294a90a3eb53
310433gabapentin 600 MG Oral TabletPSN9ead7825-d11b-4e00-8533-328d097b8f833
310434gabapentin 800 MG Oral TabletPSN9ead7825-d11b-4e00-8533-328d097b8f833
310433gabapentin 600 MG Oral TabletSCDfebf610e-e088-4797-e053-6294a90a3eb53
310433gabapentin 600 MG Oral TabletSCD10424d11-fca8-4825-8450-96d9a91908193
310433gabapentin 600 MG Oral TabletSCD9ead7825-d11b-4e00-8533-328d097b8f833
310434gabapentin 800 MG Oral TabletSCD9ead7825-d11b-4e00-8533-328d097b8f833
310433gabapentin 600 MG Oral TabletPSN7fcce531-bf7c-43b6-bea9-8f0602842c532
310433gabapentin 600 MG Oral TabletPSN1f1203f4-2184-4e13-e063-6394a90a43302
310434gabapentin 800 MG Oral TabletPSN1f1203f4-2184-4e13-e063-6394a90a43302
310433gabapentin 600 MG Oral TabletSCD7fcce531-bf7c-43b6-bea9-8f0602842c532
310433gabapentin 600 MG Oral TabletSCD1f1203f4-2184-4e13-e063-6394a90a43302
310434gabapentin 800 MG Oral TabletSCD1f1203f4-2184-4e13-e063-6394a90a43302
310433gabapentin 600 MG Oral TabletPSN934fefae-b895-427c-8798-4c5462b1ecc21
310433gabapentin 600 MG Oral TabletPSN3133c863-d33b-c9d7-e063-6294a90ae8981
310433gabapentin 600 MG Oral TabletPSN07f07d15-ee91-8c2a-e063-6394a90a46241
310434gabapentin 800 MG Oral TabletPSN934fefae-b895-427c-8798-4c5462b1ecc21
310433gabapentin 600 MG Oral TabletSCD934fefae-b895-427c-8798-4c5462b1ecc21
310433gabapentin 600 MG Oral TabletSCD07f07d15-ee91-8c2a-e063-6394a90a46241
310433gabapentin 600 MG Oral TabletSCD3133c863-d33b-c9d7-e063-6294a90ae8981
310434gabapentin 800 MG Oral TabletSCD934fefae-b895-427c-8798-4c5462b1ecc21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-166-0131722016601100 TABLET in 1 BOTTLE (31722-166-01) 100 tablet2021-10-010000-00-00NoNoCurrent
31722-166-0531722016605500 TABLET in 1 BOTTLE (31722-166-05) 500 tablet2021-10-010000-00-00NoNoCurrent