FDA.reportPublic FDA data

Gabapentin

Product NDC
64380-753
11-digit product format
643800753
Labeler code
64380
Product ID
64380-753_66c3584b-21d1-450a-8bfe-ba096129b91a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA206943
Marketing category
ANDA
Marketing start
2025-01-08
Substance
GABAPENTIN
Active strength
100 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432

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
64380-753-01Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1002
64380-753-02Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-753-01EA - Each64380-753d16c33fa-f5e6-4f3c-8dc7-7f0353e8aa2d12025-08-11
64380-753-02EA - Each64380-7537fa61e7c-ecd3-4301-b503-e78a233420d312025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-753GABAPENTIN CAPSULE [STRIDES PHARMA SCIENCE LIMITED]2Current NDC, 2 package rows20250131_798575b9-ddfa-4915-9574-626abbaf025f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN3c585b71-5cfc-18d6-e063-6294a90a3dcf3
310430gabapentin 100 MG Oral CapsulePSN798575b9-ddfa-4915-9574-626abbaf025f3
310431gabapentin 300 MG Oral CapsulePSN798575b9-ddfa-4915-9574-626abbaf025f3
310432gabapentin 400 MG Oral CapsulePSN798575b9-ddfa-4915-9574-626abbaf025f3
310430gabapentin 100 MG Oral CapsuleSCD3c585b71-5cfc-18d6-e063-6294a90a3dcf3
310430gabapentin 100 MG Oral CapsuleSCD798575b9-ddfa-4915-9574-626abbaf025f3
310431gabapentin 300 MG Oral CapsuleSCD798575b9-ddfa-4915-9574-626abbaf025f3
310432gabapentin 400 MG Oral CapsuleSCD798575b9-ddfa-4915-9574-626abbaf025f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64380-753-0164380075301100 CAPSULE in 1 BOTTLE, PLASTIC (64380-753-01) 100 capsule2025-01-08NoNoHistorical
64380-753-0264380075302500 CAPSULE in 1 BOTTLE, PLASTIC (64380-753-02) 500 capsule2025-01-08NoNoHistorical