FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-2699
11-digit product format
713352699
Labeler code
71335
Product ID
71335-2699_785531ac-f663-4045-b094-bc1338c127da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078787
Marketing category
ANDA
Marketing start
2008-01-31
Substance
GABAPENTIN
Active strength
300 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
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
71335-2699-0Gabapentin20 in 1 BOTTLECAPSULE201
71335-2699-1Gabapentin30 in 1 BOTTLECAPSULE301
71335-2699-2Gabapentin90 in 1 BOTTLECAPSULE901
71335-2699-3Gabapentin60 in 1 BOTTLECAPSULE601
71335-2699-4Gabapentin120 in 1 BOTTLECAPSULE1201
71335-2699-5Gabapentin100 in 1 BOTTLECAPSULE1001
71335-2699-6Gabapentin28 in 1 BOTTLECAPSULE281
71335-2699-7Gabapentin112 in 1 BOTTLECAPSULE1121
71335-2699-8Gabapentin84 in 1 BOTTLECAPSULE841
71335-2699-9Gabapentin180 in 1 BOTTLECAPSULE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2699-0EA - Each71335-2699fed38849-3ac2-40a6-a076-f319a445a7ab12025-11-13
71335-2699-1EA - Each71335-269977efe283-bde5-4e9b-a4cd-90783745714e12025-11-13
71335-2699-2EA - Each71335-269998428a85-c250-4103-a751-91da0869c36912025-11-13
71335-2699-3EA - Each71335-2699155df6cc-8c69-43bf-bb4e-32663f95654e12025-11-13
71335-2699-4EA - Each71335-2699ce181e56-1d65-4459-941c-a4ffd4b1ff7d12025-11-13
71335-2699-7EA - Each71335-26991f3fe359-e7ba-43a5-901b-27ee84d8aa6412025-11-13
71335-2699-9EA - Each71335-2699e97dd159-7e8c-4911-a4ea-ef3b16a8e09c12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN344d67fa-092e-4e71-b96a-25c71bfa6bb11
310431gabapentin 300 MG Oral CapsuleSCD344d67fa-092e-4e71-b96a-25c71bfa6bb11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2699-07133526990020 CAPSULE in 1 BOTTLE (71335-2699-0) 20 capsule2025-09-25NoNoHistorical
71335-2699-17133526990130 CAPSULE in 1 BOTTLE (71335-2699-1) 30 capsule2025-09-25NoNoHistorical
71335-2699-27133526990290 CAPSULE in 1 BOTTLE (71335-2699-2) 90 capsule2025-09-25NoNoHistorical
71335-2699-37133526990360 CAPSULE in 1 BOTTLE (71335-2699-3) 60 capsule2025-09-25NoNoHistorical
71335-2699-471335269904120 CAPSULE in 1 BOTTLE (71335-2699-4) 120 capsule2025-09-25NoNoHistorical
71335-2699-571335269905100 CAPSULE in 1 BOTTLE (71335-2699-5) 100 capsule2025-09-25NoNoHistorical
71335-2699-67133526990628 CAPSULE in 1 BOTTLE (71335-2699-6) 28 capsule2025-09-25NoNoHistorical
71335-2699-771335269907112 CAPSULE in 1 BOTTLE (71335-2699-7) 112 capsule2025-09-25NoNoHistorical
71335-2699-87133526990884 CAPSULE in 1 BOTTLE (71335-2699-8) 84 capsule2025-09-25NoNoHistorical
71335-2699-971335269909180 CAPSULE in 1 BOTTLE (71335-2699-9) 180 capsule2025-09-25NoNoHistorical