FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-1093
11-digit product format
713351093
Labeler code
71335
Product ID
71335-1093_6a6e1a33-d95c-4ab1-a9f9-1dada8330ca9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206943
Marketing category
ANDA
Marketing start
2018-05-14
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1093-1Gabapentin90 in 1 BOTTLECAPSULE9011
71335-1093-2Gabapentin28 in 1 BOTTLECAPSULE2811
71335-1093-3Gabapentin58 in 1 BOTTLECAPSULE5811
71335-1093-4Gabapentin30 in 1 BOTTLECAPSULE3011
71335-1093-5Gabapentin60 in 1 BOTTLECAPSULE6011
71335-1093-6Gabapentin120 in 1 BOTTLECAPSULE12011
71335-1093-7Gabapentin180 in 1 BOTTLECAPSULE18011
71335-1093-8Gabapentin40 in 1 BOTTLECAPSULE4011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1093-1EA - Each71335-10936cf40e60-ada4-4e16-9e89-8d1a1f5f2b8612019-11-12
71335-1093-6EA - Each71335-1093c239a553-a828-4787-ba1f-0e3b76c90bf312020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1093GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 8 package rows20240410_01b810b7-f4c8-4412-bbc5-b9220d8770d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN01b810b7-f4c8-4412-bbc5-b9220d8770d811
310431gabapentin 300 MG Oral CapsuleSCD01b810b7-f4c8-4412-bbc5-b9220d8770d811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1093-17133510930190 CAPSULE in 1 BOTTLE (71335-1093-1) 90 capsule2024-04-020000-00-00NoNoCurrent
71335-1093-27133510930228 CAPSULE in 1 BOTTLE (71335-1093-2) 28 capsule2024-04-020000-00-00NoNoCurrent
71335-1093-37133510930358 CAPSULE in 1 BOTTLE (71335-1093-3) 58 capsule2024-04-020000-00-00NoNoCurrent
71335-1093-47133510930430 CAPSULE in 1 BOTTLE (71335-1093-4) 30 capsule2019-02-070000-00-00NoNoCurrent
71335-1093-57133510930560 CAPSULE in 1 BOTTLE (71335-1093-5) 60 capsule2019-02-220000-00-00NoNoCurrent
71335-1093-671335109306120 CAPSULE in 1 BOTTLE (71335-1093-6) 120 capsule2019-04-170000-00-00NoNoCurrent
71335-1093-771335109307180 CAPSULE in 1 BOTTLE (71335-1093-7) 180 capsule2020-06-080000-00-00NoNoCurrent
71335-1093-87133510930840 CAPSULE in 1 BOTTLE (71335-1093-8) 40 capsule2024-04-020000-00-00NoNoCurrent