FDA.reportPublic FDA data

Gabapentin

Product NDC
71205-808
11-digit product format
712050808
Labeler code
71205
Product ID
71205-808_22f2294f-352a-4515-87c8-a6ae46e61322
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-04-01
Substance
GABAPENTIN
Active strength
400 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
GABAPENTIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310432

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
71205-808-30Gabapentin30 in 1 BOTTLECAPSULE301
71205-808-60Gabapentin60 in 1 BOTTLECAPSULE601
71205-808-90Gabapentin90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-808-90EA - Each71205-808cebc9b45-f830-4477-a5c6-3456f67ebb7012023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-808GABAPENTIN CAPSULE [PROFICIENT RX LP]1Current NDC, 3 package rows20230528_22f2294f-352a-4515-87c8-a6ae46e61322.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSN22f2294f-352a-4515-87c8-a6ae46e613221
310432gabapentin 400 MG Oral CapsuleSCD22f2294f-352a-4515-87c8-a6ae46e613221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-808-307120508083030 CAPSULE in 1 BOTTLE (71205-808-30) 30 capsule2023-05-25NoNoCurrent
71205-808-607120508086060 CAPSULE in 1 BOTTLE (71205-808-60) 60 capsule2023-05-25NoNoCurrent
71205-808-907120508089090 CAPSULE in 1 BOTTLE (71205-808-90) 90 capsule2023-05-25NoNoCurrent