FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-2700
11-digit product format
713352700
Labeler code
71335
Product ID
71335-2700_a589821b-45d0-4a53-b61d-694f109f3711
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
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
Rxcui310432

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
71335-2700-0Gabapentin180 in 1 BOTTLECAPSULE1801
71335-2700-1Gabapentin20 in 1 BOTTLECAPSULE201
71335-2700-2Gabapentin90 in 1 BOTTLECAPSULE901
71335-2700-3Gabapentin60 in 1 BOTTLECAPSULE601
71335-2700-4Gabapentin30 in 1 BOTTLECAPSULE301
71335-2700-5Gabapentin120 in 1 BOTTLECAPSULE1201
71335-2700-6Gabapentin21 in 1 BOTTLECAPSULE211
71335-2700-7Gabapentin84 in 1 BOTTLECAPSULE841
71335-2700-8Gabapentin112 in 1 BOTTLECAPSULE1121
71335-2700-9Gabapentin28 in 1 BOTTLECAPSULE281

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2700-0EA - Each71335-2700bc00dabf-e974-464a-a70d-1d0fe563162212026-05-22
71335-2700-1EA - Each71335-2700401aa904-318d-4220-8baa-95067643683612026-05-22
71335-2700-2EA - Each71335-27005fd94787-9112-4d62-bdcf-87ee99c274f212026-05-22
71335-2700-3EA - Each71335-2700d878f99a-691f-4b49-acef-97436df1921712026-05-22
71335-2700-4EA - Each71335-2700b848d4a2-7058-4cc1-9df9-995dd884aee212026-05-22
71335-2700-5EA - Each71335-270062ef0f3b-59a1-4103-8233-de8952914a5012026-05-22
71335-2700-6EA - Each71335-2700a0b74f79-13a1-482e-836a-d204f309c1d412026-05-22
71335-2700-7EA - Each71335-2700619e1934-7b3b-43a0-b107-42fc5fee100912026-05-22
71335-2700-8EA - Each71335-27009ad4ded6-a0b8-45e7-9344-f432319a950912026-05-22
71335-2700-9EA - Each71335-27004925002e-adff-449b-8ca1-a5084085326412026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSNbc1316b6-1fc4-4990-95a8-4898817728761
310432gabapentin 400 MG Oral CapsuleSCDbc1316b6-1fc4-4990-95a8-4898817728761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2700-071335270000180 CAPSULE in 1 BOTTLE (71335-2700-0) 180 capsule2025-09-25NoNoHistorical
71335-2700-17133527000120 CAPSULE in 1 BOTTLE (71335-2700-1) 20 capsule2025-09-25NoNoHistorical
71335-2700-27133527000290 CAPSULE in 1 BOTTLE (71335-2700-2) 90 capsule2025-09-25NoNoHistorical
71335-2700-37133527000360 CAPSULE in 1 BOTTLE (71335-2700-3) 60 capsule2025-09-25NoNoHistorical
71335-2700-47133527000430 CAPSULE in 1 BOTTLE (71335-2700-4) 30 capsule2025-09-25NoNoHistorical
71335-2700-571335270005120 CAPSULE in 1 BOTTLE (71335-2700-5) 120 capsule2025-09-25NoNoHistorical
71335-2700-67133527000621 CAPSULE in 1 BOTTLE (71335-2700-6) 21 capsule2025-09-25NoNoHistorical
71335-2700-77133527000784 CAPSULE in 1 BOTTLE (71335-2700-7) 84 capsule2025-09-25NoNoHistorical
71335-2700-871335270008112 CAPSULE in 1 BOTTLE (71335-2700-8) 112 capsule2025-09-25NoNoHistorical
71335-2700-97133527000928 CAPSULE in 1 BOTTLE (71335-2700-9) 28 capsule2025-09-25NoNoHistorical