Gabapentin

Product NDC
63629-8487
11-digit product format
636298487
Labeler code
63629
Product ID
63629-8487_3d1ed089-89bf-4c4c-b32b-235324035e5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-02-18
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2027-12-31

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
63629-8487-1Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE100105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8487-1EA - Each63629-8487cc423ed1-d39f-4b7b-b201-d3597db4c0a512021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8487GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20240418_2ac0622c-440a-49a0-974f-726e6ac72a0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN2ac0622c-440a-49a0-974f-726e6ac72a0e105
310431gabapentin 300 MG Oral CapsuleSCD2ac0622c-440a-49a0-974f-726e6ac72a0e105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8487-163629848701100 CAPSULE in 1 BOTTLE, PLASTIC (63629-8487-1) 100 capsule2018-08-200000-00-00NoNoCurrent