GABAPENTIN

Product NDC
63187-909
11-digit product format
631870909
Labeler code
63187
Product ID
63187-909_563dace5-c1ab-46ff-b3f9-774fe2a62ca5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090705
Marketing category
ANDA
Marketing start
2016-06-29
Substance
GABAPENTIN
Active strength
400 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
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
63187-909-00GABAPENTIN100 in 1 BOTTLECAPSULE1003
63187-909-30GABAPENTIN30 in 1 BOTTLECAPSULE303
63187-909-60GABAPENTIN60 in 1 BOTTLECAPSULE603
63187-909-72GABAPENTIN120 in 1 BOTTLECAPSULE1203
63187-909-90GABAPENTIN90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-909-30EA - Each63187-909e94e2bb1-c380-41bf-9712-9ab2a311cb9912017-11-06
63187-909-90EA - Each63187-909d0576302-6819-4c51-9d33-5020d1670bfe12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-909GABAPENTIN CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 5 package rows20191108_92c4d589-533b-4fe4-833f-dd68cc1f7e66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSN92c4d589-533b-4fe4-833f-dd68cc1f7e663
310432gabapentin 400 MG Oral CapsuleSCD92c4d589-533b-4fe4-833f-dd68cc1f7e663

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-909-0063187090900100 CAPSULE in 1 BOTTLE (63187-909-00) 100 capsule2017-09-010000-00-00NoNoCurrent
63187-909-306318709093030 CAPSULE in 1 BOTTLE (63187-909-30) 30 capsule2017-09-010000-00-00NoNoCurrent
63187-909-606318709096060 CAPSULE in 1 BOTTLE (63187-909-60) 60 capsule2017-09-010000-00-00NoNoCurrent
63187-909-7263187090972120 CAPSULE in 1 BOTTLE (63187-909-72) 120 capsule2017-09-010000-00-00NoNoCurrent
63187-909-906318709099090 CAPSULE in 1 BOTTLE (63187-909-90) 90 capsule2017-09-010000-00-00NoNoCurrent