FDA.reportPublic FDA data

Gabapentin

Product NDC
71205-638
11-digit product format
712050638
Labeler code
71205
Product ID
71205-638_092356cf-c100-4bd5-8a3f-c4b2e66ee462
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
100 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
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430

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
71205-638-30Gabapentin30 in 1 BOTTLECAPSULE302
71205-638-60Gabapentin60 in 1 BOTTLECAPSULE602
71205-638-90Gabapentin90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-638-30EA - Each71205-638d32c525c-c9fd-4628-b6f5-6121e981e40312022-04-06
71205-638-90EA - Each71205-638cb5a9a2b-81e5-4fea-b5f1-58b99293569f12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-638GABAPENTIN CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220513_ed22b78e-93ff-4cb5-9c9c-2afe9b60dd2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNed22b78e-93ff-4cb5-9c9c-2afe9b60dd2e2
310430gabapentin 100 MG Oral CapsuleSCDed22b78e-93ff-4cb5-9c9c-2afe9b60dd2e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-638-307120506383030 CAPSULE in 1 BOTTLE (71205-638-30) 30 capsule2022-02-090000-00-00NoNoCurrent
71205-638-607120506386060 CAPSULE in 1 BOTTLE (71205-638-60) 60 capsule2022-02-090000-00-00NoNoCurrent
71205-638-907120506389090 CAPSULE in 1 BOTTLE (71205-638-90) 90 capsule2022-02-090000-00-00NoNoCurrent