FDA.reportPublic FDA data

Gabapentin

Product NDC
60760-674
11-digit product format
607600674
Labeler code
60760
Product ID
60760-674_45380b1f-d872-6c92-e063-6294a90aa63c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA207099
Marketing category
ANDA
Marketing start
2022-08-01
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60760-674-30Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE304
60760-674-60Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE604
60760-674-90Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-674-30EA - Each60760-67436833005-65bf-454d-a288-51feb5f8105e12025-05-14
60760-674-60EA - Each60760-67442ec226d-6a42-47e0-9f34-c9d88ddf51eb12025-05-14
60760-674-90EA - Each60760-6740d5fcba4-bf32-44ab-ba5f-921f34cc634412025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-674GABAPENTIN CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY]3Current NDC, 3 package rows20250425_2bc65375-77b8-1e50-e063-6294a90acf8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN2bc65375-77b8-1e50-e063-6294a90acf8f4
310431gabapentin 300 MG Oral CapsuleSCD2bc65375-77b8-1e50-e063-6294a90acf8f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-674-306076006743030 CAPSULE in 1 BOTTLE, PLASTIC (60760-674-30) 30 capsule2025-04-23NoNoCurrent
60760-674-606076006746060 CAPSULE in 1 BOTTLE, PLASTIC (60760-674-60) 60 capsule2025-02-13NoNoCurrent
60760-674-906076006749090 CAPSULE in 1 BOTTLE, PLASTIC (60760-674-90) 90 capsule2025-01-09NoNoCurrent