FDA.reportPublic FDA data

Gabapentin

Product NDC
80425-0199
11-digit product format
804250199
Labeler code
80425
Product ID
80425-0199_2a99a80e-d075-27e6-e063-6294a90ae0fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA075477
Marketing category
ANDA
Marketing start
2022-10-28
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
2026-12-31

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
80425-0199-1Gabapentin30 in 1 BOTTLECAPSULE305
80425-0199-2Gabapentin60 in 1 BOTTLECAPSULE605
80425-0199-3Gabapentin90 in 1 BOTTLECAPSULE905
80425-0199-4Gabapentin120 in 1 BOTTLECAPSULE1205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0199-1EA - Each80425-0199d68dc437-0849-41c2-b17b-257d12f6b61c12023-06-06
80425-0199-2EA - Each80425-019972852c7a-f605-4712-bd72-41cd7fab807812023-06-06
80425-0199-3EA - Each80425-0199d088f4ae-c84a-47de-954a-d5659921b2bf12023-06-06
80425-0199-4EA - Each80425-019923d7cfee-4b7b-41a1-a066-247e8cdd763e12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0199GABAPENTIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 4 package rows20250101_ec1c621b-db2a-1567-e053-2995a90a8695.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNec1c621b-db2a-1567-e053-2995a90a86955
310430gabapentin 100 MG Oral CapsuleSCDec1c621b-db2a-1567-e053-2995a90a86955

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0199-18042501990130 CAPSULE in 1 BOTTLE (80425-0199-1) 30 capsule2023-03-30NoNoCurrent
80425-0199-28042501990260 CAPSULE in 1 BOTTLE (80425-0199-2) 60 capsule2023-10-28NoNoCurrent
80425-0199-38042501990390 CAPSULE in 1 BOTTLE (80425-0199-3) 90 capsule2023-10-28NoNoCurrent
80425-0199-480425019904120 CAPSULE in 1 BOTTLE (80425-0199-4) 120 capsule2023-03-30NoNoCurrent