FDA.reportPublic FDA data

Gabapentin

Product NDC
80425-0033
11-digit product format
804250033
Labeler code
80425
Product ID
80425-0033_4d628103-5e90-0a21-e063-6394a90a484e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA090858
Marketing category
ANDA
Marketing start
2011-01-29
Substance
GABAPENTIN
Active strength
300 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
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
80425-0033-1Gabapentin30 in 1 BOTTLECAPSULE3012
80425-0033-2Gabapentin60 in 1 BOTTLECAPSULE6012
80425-0033-3Gabapentin90 in 1 BOTTLECAPSULE9012
80425-0033-4Gabapentin40 in 1 BOTTLECAPSULE4012
80425-0033-5Gabapentin120 in 1 BOTTLECAPSULE12012
80425-0033-6Gabapentin9 in 1 BOTTLECAPSULE912

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0033-1EA - Each80425-00339436a3ad-de85-4153-a6c1-1bc48a0c0ea912023-06-06
80425-0033-2EA - Each80425-0033f1d09a02-72a4-486f-a426-6c8d6d9fd95612023-06-06
80425-0033-3EA - Each80425-003398f4b8be-49fb-4eaa-b05b-544343fd0e0512023-06-06
80425-0033-4EA - Each80425-0033a3084993-3234-4a78-b106-1d887c7721c412023-06-06
80425-0033-5EA - Each80425-0033869fe2d3-45a1-4521-b1b8-9b0a2897691212025-03-04
80425-0033-6EA - Each80425-00332cb2f884-e0fb-4a65-b21b-67d983685b7512026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0033GABAPENTIN CAPSULE [ADVANCED RX OF TENNESSEE, LLC]10Current NDC, Legacy NDC, 6 package rows20250221_afc83432-8fce-6d2a-e053-2a95a90ae73f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNafc83432-8fce-6d2a-e053-2a95a90ae73f12
310431gabapentin 300 MG Oral CapsuleSCDafc83432-8fce-6d2a-e053-2a95a90ae73f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0033-18042500330130 CAPSULE in 1 BOTTLE (80425-0033-1) 30 capsule2011-01-290000-00-00NoNoCurrent
80425-0033-28042500330260 CAPSULE in 1 BOTTLE (80425-0033-2) 60 capsule2011-01-290000-00-00NoNoCurrent
80425-0033-38042500330390 CAPSULE in 1 BOTTLE (80425-0033-3) 90 capsule2011-01-290000-00-00NoNoCurrent
80425-0033-48042500330440 CAPSULE in 1 BOTTLE (80425-0033-4) 40 capsule2011-01-290000-00-00NoNoCurrent
80425-0033-580425003305120 CAPSULE in 1 BOTTLE (80425-0033-5) 120 capsule2025-02-18NoNoHistorical
80425-0033-6804250033069 CAPSULE in 1 BOTTLE (80425-0033-6) 9 capsule2011-01-29NoNoHistorical