FDA.reportPublic FDA data

Gabapentin

Product NDC
72789-289
11-digit product format
727890289
Labeler code
72789
Product ID
72789-289_4badb0d6-c979-2f30-e063-6294a90a1e7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-02-18
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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

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
72789-289-30Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE3018
72789-289-60Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE6018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-289-30EA - Each72789-289eae2f27f-6e32-4a39-8c2e-51c42640a5dc12023-02-06
72789-289-60EA - Each72789-2890edacc18-2539-4eed-a657-a6d1acad9ab512025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-289GABAPENTIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 2 package rows20240220_4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a18
310430gabapentin 100 MG Oral CapsuleSCD4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-289-307278902893030 CAPSULE in 1 BOTTLE, PLASTIC (72789-289-30) 30 capsule2022-12-050000-00-00NoNoCurrent
72789-289-607278902896060 CAPSULE in 1 BOTTLE, PLASTIC (72789-289-60) 60 capsule2025-05-29NoNoHistorical