FDA.reportPublic FDA data

Gabapentin

Product NDC
71335-1199
11-digit product format
713351199
Labeler code
71335
Product ID
71335-1199_876f9c53-75e7-4101-b78f-46a009ba119d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090858
Marketing category
ANDA
Marketing start
2011-01-29
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
71335-1199-0Gabapentin180 in 1 BOTTLECAPSULE180105
71335-1199-1Gabapentin20 in 1 BOTTLECAPSULE20105
71335-1199-2Gabapentin90 in 1 BOTTLECAPSULE90105
71335-1199-3Gabapentin60 in 1 BOTTLECAPSULE60105
71335-1199-4Gabapentin30 in 1 BOTTLECAPSULE30105
71335-1199-5Gabapentin120 in 1 BOTTLECAPSULE120105
71335-1199-6Gabapentin21 in 1 BOTTLECAPSULE21105
71335-1199-7Gabapentin84 in 1 BOTTLECAPSULE84105
71335-1199-8Gabapentin112 in 1 BOTTLECAPSULE112105
71335-1199-9Gabapentin28 in 1 BOTTLECAPSULE28105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1199-2EA - Each71335-1199b2026657-4323-4136-8edf-56af94c7358d12020-01-03
71335-1199-3EA - Each71335-1199afe4aaf7-6876-46a0-820c-c847e0f2414d12022-04-06
71335-1199-5EA - Each71335-1199bd3bcb5b-dd33-4199-a51c-349c2b67de2b12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1199GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 10 package rows20250224_eb2f6784-e7be-41b6-871b-2c3c961664ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSNeb2f6784-e7be-41b6-871b-2c3c961664ab105
310432gabapentin 400 MG Oral CapsuleSCDeb2f6784-e7be-41b6-871b-2c3c961664ab105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1199-071335119900180 CAPSULE in 1 BOTTLE (71335-1199-0) 180 capsule2025-01-290000-00-00NoNoCurrent
71335-1199-17133511990120 CAPSULE in 1 BOTTLE (71335-1199-1) 20 capsule2025-01-290000-00-00NoNoCurrent
71335-1199-27133511990290 CAPSULE in 1 BOTTLE (71335-1199-2) 90 capsule2019-05-070000-00-00NoNoCurrent
71335-1199-37133511990360 CAPSULE in 1 BOTTLE (71335-1199-3) 60 capsule2019-05-020000-00-00NoNoCurrent
71335-1199-47133511990430 CAPSULE in 1 BOTTLE (71335-1199-4) 30 capsule2019-05-290000-00-00NoNoCurrent
71335-1199-571335119905120 CAPSULE in 1 BOTTLE (71335-1199-5) 120 capsule2022-02-110000-00-00NoNoCurrent
71335-1199-67133511990621 CAPSULE in 1 BOTTLE (71335-1199-6) 21 capsule2025-01-290000-00-00NoNoCurrent
71335-1199-77133511990784 CAPSULE in 1 BOTTLE (71335-1199-7) 84 capsule2025-01-290000-00-00NoNoCurrent
71335-1199-871335119908112 CAPSULE in 1 BOTTLE (71335-1199-8) 112 capsule2025-01-290000-00-00NoNoCurrent
71335-1199-97133511990928 CAPSULE in 1 BOTTLE (71335-1199-9) 28 capsule2025-01-290000-00-00NoNoCurrent