FDA.reportPublic FDA data

Gabapentin

Product NDC
72789-055
11-digit product format
727890055
Labeler code
72789
Product ID
72789-055_3ca9c072-d910-4e73-e063-6394a90a7223
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA075350
Marketing category
ANDA
Marketing start
2014-04-03
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
72789-055-30Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE3024
72789-055-45Gabapentin45 in 1 BOTTLE, PLASTICCAPSULE4524
72789-055-60Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE6024
72789-055-90Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE9024
72789-055-93Gabapentin180 in 1 BOTTLE, PLASTICCAPSULE18024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-055-30EA - Each72789-055a1500841-95d4-4ca7-a2e8-509ed5f6f4e312020-04-20
72789-055-60EA - Each72789-055f2c7f02f-e66e-4787-b8a1-efdabd9e985a12020-04-20
72789-055-90EA - Each72789-055def5c072-0c65-4c5f-b424-b48f02fa2ab712020-04-20
72789-055-93EA - Each72789-0554be85380-fc8b-4ef8-a857-ebff6b5f7c1f12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-055GABAPENTIN CAPSULE [PD-RX PHARMACEUTICALS, INC.]23Current NDC, Legacy NDC, 5 package rows20241003_b4c7388a-19d9-4e3a-83c9-4943fb855be4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNb4c7388a-19d9-4e3a-83c9-4943fb855be424
310431gabapentin 300 MG Oral CapsuleSCDb4c7388a-19d9-4e3a-83c9-4943fb855be424

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-055-307278900553030 CAPSULE in 1 BOTTLE, PLASTIC (72789-055-30) 30 capsule2020-02-240000-00-00NoNoCurrent
72789-055-457278900554545 CAPSULE in 1 BOTTLE, PLASTIC (72789-055-45) 45 capsule2020-09-090000-00-00NoNoCurrent
72789-055-607278900556060 CAPSULE in 1 BOTTLE, PLASTIC (72789-055-60) 60 capsule2020-09-090000-00-00NoNoCurrent
72789-055-907278900559090 CAPSULE in 1 BOTTLE, PLASTIC (72789-055-90) 90 capsule2020-02-240000-00-00NoNoCurrent
72789-055-9372789005593180 CAPSULE in 1 BOTTLE, PLASTIC (72789-055-93) 180 capsule2020-06-160000-00-00NoNoCurrent