FDA.reportPublic FDA data

Gabapentin

Product NDC
71205-532
11-digit product format
712050532
Labeler code
71205
Product ID
71205-532_3b668584-ca03-409b-b016-10c252899d4c
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
300 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], 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
71205-532-14Gabapentin14 in 1 BOTTLECAPSULE144
71205-532-15Gabapentin15 in 1 BOTTLECAPSULE154
71205-532-30Gabapentin30 in 1 BOTTLECAPSULE304
71205-532-60Gabapentin60 in 1 BOTTLECAPSULE604
71205-532-72Gabapentin120 in 1 BOTTLECAPSULE1204
71205-532-90Gabapentin90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-532-14EA - Each71205-532f77fb313-2492-47ca-a9ab-302bba9201dd12022-03-09
71205-532-15EA - Each71205-5328c018a3c-7fea-4556-be98-fe57b56810ac12021-06-02
71205-532-30EA - Each71205-53201f3eb41-4a79-432c-b91b-f22be41f576312021-04-08
71205-532-60EA - Each71205-532076d9d4d-87a6-4a07-abd1-10295ee8b8a312021-06-02
71205-532-72EA - Each71205-532886dedd3-9d26-493d-9054-086db2bcac8b12021-07-15
71205-532-90EA - Each71205-532ab173e61-2d6d-4e4f-98e4-1de320648c8412021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-532GABAPENTIN CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 6 package rows20220426_223a9216-6e07-49b9-8faf-bb4e529a6ae5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN223a9216-6e07-49b9-8faf-bb4e529a6ae54
310431gabapentin 300 MG Oral CapsuleSCD223a9216-6e07-49b9-8faf-bb4e529a6ae54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-532-147120505321414 CAPSULE in 1 BOTTLE (71205-532-14) 14 capsule2022-01-050000-00-00NoNoCurrent
71205-532-157120505321515 CAPSULE in 1 BOTTLE (71205-532-15) 15 capsule2021-02-040000-00-00NoNoCurrent
71205-532-307120505323030 CAPSULE in 1 BOTTLE (71205-532-30) 30 capsule2021-02-040000-00-00NoNoCurrent
71205-532-607120505326060 CAPSULE in 1 BOTTLE (71205-532-60) 60 capsule2021-02-040000-00-00NoNoCurrent
71205-532-7271205053272120 CAPSULE in 1 BOTTLE (71205-532-72) 120 capsule2021-05-250000-00-00NoNoCurrent
71205-532-907120505329090 CAPSULE in 1 BOTTLE (71205-532-90) 90 capsule2021-02-040000-00-00NoNoCurrent