Gabapentin

Product NDC
82804-203
11-digit product format
828040203
Labeler code
82804
Product ID
82804-203_fd2ec86d-8c7a-4556-9069-91d60c7d47b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA207057
Marketing category
ANDA
Marketing start
2021-11-01
Substance
GABAPENTIN
Active strength
800 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
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310434

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
82804-203-30Gabapentin30 in 1 BOTTLE, PLASTICTABLET, COATED302
82804-203-60Gabapentin60 in 1 BOTTLE, PLASTICTABLET, COATED602
82804-203-90Gabapentin90 in 1 BOTTLE, PLASTICTABLET, COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-203GABAPENTIN TABLET, COATED [PROFICIENT RX LP]2Current NDC, 3 package rows20250326_87b9171b-7d00-40fa-87ff-a717740efe8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310434gabapentin 800 MG Oral TabletPSN87b9171b-7d00-40fa-87ff-a717740efe8a2
310434gabapentin 800 MG Oral TabletSCD87b9171b-7d00-40fa-87ff-a717740efe8a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-203-308280402033030 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-203-30) 2025-03-19NoNoCurrent
82804-203-608280402036060 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-203-60) 2025-03-05NoNoCurrent
82804-203-908280402039090 TABLET, COATED in 1 BOTTLE, PLASTIC (82804-203-90) 2025-03-05NoNoCurrent