FDA.reportPublic FDA data

GABAPENTIN

Product NDC
31722-150
11-digit product format
317220150
Labeler code
31722
Product ID
31722-150_2a2c08de-b06c-4926-e063-6394a90a2eb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA214956
Marketing category
ANDA
Marketing start
2021-05-10
Substance
GABAPENTIN
Active strength
400 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
GABAPENTIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
31722-150-01GABAPENTIN100 in 1 BOTTLECAPSULE1003
31722-150-05GABAPENTIN500 in 1 BOTTLECAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-150-01EA - Each31722-150b77f1e51-bf45-45fd-8030-e4ca61d8339612021-12-08
31722-150-05EA - Each31722-1504bdea9a9-a9bb-429b-9863-873c1ade8fff12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-150GABAPENTIN (GABAPENTIN) CAPSULE [CAMBER PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20241228_e8a30eb7-3fc5-456a-bdae-3f4095bf2c2b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNe8a30eb7-3fc5-456a-bdae-3f4095bf2c2b3
310431gabapentin 300 MG Oral CapsulePSNe8a30eb7-3fc5-456a-bdae-3f4095bf2c2b3
310432gabapentin 400 MG Oral CapsulePSNe8a30eb7-3fc5-456a-bdae-3f4095bf2c2b3
310430gabapentin 100 MG Oral CapsuleSCDe8a30eb7-3fc5-456a-bdae-3f4095bf2c2b3
310431gabapentin 300 MG Oral CapsuleSCDe8a30eb7-3fc5-456a-bdae-3f4095bf2c2b3
310432gabapentin 400 MG Oral CapsuleSCDe8a30eb7-3fc5-456a-bdae-3f4095bf2c2b3
310430gabapentin 100 MG Oral CapsulePSN17a62334-209d-4dc1-867a-e5780196a2ca1
310431gabapentin 300 MG Oral CapsulePSN17a62334-209d-4dc1-867a-e5780196a2ca1
310432gabapentin 400 MG Oral CapsulePSN17a62334-209d-4dc1-867a-e5780196a2ca1
310430gabapentin 100 MG Oral CapsuleSCD17a62334-209d-4dc1-867a-e5780196a2ca1
310431gabapentin 300 MG Oral CapsuleSCD17a62334-209d-4dc1-867a-e5780196a2ca1
310432gabapentin 400 MG Oral CapsuleSCD17a62334-209d-4dc1-867a-e5780196a2ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-150-0131722015001100 CAPSULE in 1 BOTTLE (31722-150-01) 100 capsule2021-05-100000-00-00NoNoCurrent
31722-150-0531722015005500 CAPSULE in 1 BOTTLE (31722-150-05) 500 capsule2021-05-100000-00-00NoNoCurrent