FDA.reportPublic FDA data

GABAPENTIN

Product NDC
71335-0993
11-digit product format
713350993
Labeler code
71335
Product ID
71335-0993_424a9673-5bd1-4a75-8b1f-09a69b5043c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090007
Marketing category
ANDA
Marketing start
2015-12-30
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
71335-0993-1GABAPENTIN90 in 1 BOTTLECAPSULE906
71335-0993-2GABAPENTIN28 in 1 BOTTLECAPSULE286
71335-0993-3GABAPENTIN58 in 1 BOTTLECAPSULE586
71335-0993-4GABAPENTIN30 in 1 BOTTLECAPSULE306
71335-0993-5GABAPENTIN60 in 1 BOTTLECAPSULE606
71335-0993-6GABAPENTIN120 in 1 BOTTLECAPSULE1206
71335-0993-7GABAPENTIN180 in 1 BOTTLECAPSULE1806
71335-0993-8GABAPENTIN40 in 1 BOTTLECAPSULE406

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0993-1EA - Each71335-099372edf82c-4697-4411-bf1d-bc32cafccf4a12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0993GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 8 package rows20241116_78088f6a-06a3-422f-b336-4a57a24adc16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN78088f6a-06a3-422f-b336-4a57a24adc166
310431gabapentin 300 MG Oral CapsuleSCD78088f6a-06a3-422f-b336-4a57a24adc166

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0993-17133509930190 CAPSULE in 1 BOTTLE (71335-0993-1) 90 capsule2018-11-020000-00-00NoNoCurrent
71335-0993-27133509930228 CAPSULE in 1 BOTTLE (71335-0993-2) 28 capsule2024-10-300000-00-00NoNoCurrent
71335-0993-37133509930358 CAPSULE in 1 BOTTLE (71335-0993-3) 58 capsule2024-10-300000-00-00NoNoCurrent
71335-0993-47133509930430 CAPSULE in 1 BOTTLE (71335-0993-4) 30 capsule2020-02-200000-00-00NoNoCurrent
71335-0993-57133509930560 CAPSULE in 1 BOTTLE (71335-0993-5) 60 capsule2020-02-180000-00-00NoNoCurrent
71335-0993-671335099306120 CAPSULE in 1 BOTTLE (71335-0993-6) 120 capsule2018-11-070000-00-00NoNoCurrent
71335-0993-771335099307180 CAPSULE in 1 BOTTLE (71335-0993-7) 180 capsule2022-01-140000-00-00NoNoCurrent
71335-0993-87133509930840 CAPSULE in 1 BOTTLE (71335-0993-8) 40 capsule2024-10-300000-00-00NoNoCurrent