FDA.reportPublic FDA data

Gabapentin

Product NDC
80425-0196
11-digit product format
804250196
Labeler code
80425
Product ID
80425-0196_2a99bd40-3c52-3207-e063-6294a90a4faa
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
2022-10-26
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
80425-0196-1Gabapentin30 in 1 BOTTLECAPSULE305
80425-0196-2Gabapentin60 in 1 BOTTLECAPSULE605
80425-0196-3Gabapentin90 in 1 BOTTLECAPSULE905
80425-0196-4Gabapentin120 in 1 BOTTLECAPSULE1205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0196-1EA - Each80425-019693d9815a-7064-409b-9104-c58f8ff0a66412023-04-07
80425-0196-2EA - Each80425-0196be275f30-163c-450f-b9ee-cc052bbf064912023-04-07
80425-0196-3EA - Each80425-01966f60d0cc-519a-4a2a-8986-64219942a8a512023-04-07
80425-0196-4EA - Each80425-019656611bea-6d96-4003-a682-aabccae55aff12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0196GABAPENTIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]5Current NDC, Legacy NDC, 4 package rows20250101_ebf57adf-b066-2959-e053-2a95a90a961c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNebf57adf-b066-2959-e053-2a95a90a961c5
310431gabapentin 300 MG Oral CapsuleSCDebf57adf-b066-2959-e053-2a95a90a961c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0196-18042501960130 CAPSULE in 1 BOTTLE (80425-0196-1) 30 capsule2023-10-26NoNoCurrent
80425-0196-28042501960260 CAPSULE in 1 BOTTLE (80425-0196-2) 60 capsule2023-10-26NoNoCurrent
80425-0196-38042501960390 CAPSULE in 1 BOTTLE (80425-0196-3) 90 capsule2023-10-26NoNoCurrent
80425-0196-480425019604120 CAPSULE in 1 BOTTLE (80425-0196-4) 120 capsule2023-03-30NoNoCurrent