FDA.reportPublic FDA data

GABAPENTIN

Product NDC
71335-1490
11-digit product format
713351490
Labeler code
71335
Product ID
71335-1490_37db017a-5023-4af8-b0af-994aa1507c1f
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
71335-1490-0GABAPENTIN20 in 1 BOTTLECAPSULE206
71335-1490-1GABAPENTIN30 in 1 BOTTLECAPSULE306
71335-1490-2GABAPENTIN90 in 1 BOTTLECAPSULE906
71335-1490-3GABAPENTIN60 in 1 BOTTLECAPSULE606
71335-1490-4GABAPENTIN120 in 1 BOTTLECAPSULE1206
71335-1490-5GABAPENTIN100 in 1 BOTTLECAPSULE1006
71335-1490-6GABAPENTIN28 in 1 BOTTLECAPSULE286
71335-1490-7GABAPENTIN112 in 1 BOTTLECAPSULE1126
71335-1490-8GABAPENTIN84 in 1 BOTTLECAPSULE846
71335-1490-9GABAPENTIN180 in 1 BOTTLECAPSULE1806

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1490-0EA - Each71335-149028ee024b-4803-4958-9d23-62005a98e07d12022-06-06
71335-1490-1EA - Each71335-14900670b4bf-92f4-46a7-a151-4f68b1adf2b812022-06-06
71335-1490-3EA - Each71335-14904967643b-3295-4d83-98ce-bb32b90f621f12022-06-06
71335-1490-4EA - Each71335-149073adc1b4-e1bd-4d03-b8ba-5f098d8d4c2e12022-06-06
71335-1490-5EA - Each71335-1490f488f583-4b27-48d4-9a1d-a12f95ba351812022-06-06
71335-1490-9EA - Each71335-1490eb87786b-09bb-4909-98c5-30ba8481544712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1490GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 10 package rows20241120_c33c4d83-cc13-4104-9e24-d4cd40b17b70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNc33c4d83-cc13-4104-9e24-d4cd40b17b706
310431gabapentin 300 MG Oral CapsuleSCDc33c4d83-cc13-4104-9e24-d4cd40b17b706

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1490-07133514900020 CAPSULE in 1 BOTTLE (71335-1490-0) 20 capsule2022-03-010000-00-00NoNoCurrent
71335-1490-17133514900130 CAPSULE in 1 BOTTLE (71335-1490-1) 30 capsule2022-02-070000-00-00NoNoCurrent
71335-1490-27133514900290 CAPSULE in 1 BOTTLE (71335-1490-2) 90 capsule2020-02-140000-00-00NoNoCurrent
71335-1490-37133514900360 CAPSULE in 1 BOTTLE (71335-1490-3) 60 capsule2022-02-160000-00-00NoNoCurrent
71335-1490-471335149004120 CAPSULE in 1 BOTTLE (71335-1490-4) 120 capsule2020-03-230000-00-00NoNoCurrent
71335-1490-571335149005100 CAPSULE in 1 BOTTLE (71335-1490-5) 100 capsule2020-03-160000-00-00NoNoCurrent
71335-1490-67133514900628 CAPSULE in 1 BOTTLE (71335-1490-6) 28 capsule2024-10-310000-00-00NoNoCurrent
71335-1490-771335149007112 CAPSULE in 1 BOTTLE (71335-1490-7) 112 capsule2024-10-310000-00-00NoNoCurrent
71335-1490-87133514900884 CAPSULE in 1 BOTTLE (71335-1490-8) 84 capsule2024-10-310000-00-00NoNoCurrent
71335-1490-971335149009180 CAPSULE in 1 BOTTLE (71335-1490-9) 180 capsule2020-03-250000-00-00NoNoCurrent