FDA.reportPublic FDA data

GABAPENTIN

Product NDC
72189-109
11-digit product format
721890109
Labeler code
72189
Product ID
72189-109_2becf606-de3d-b686-e063-6294a90afe58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090007
Marketing category
ANDA
Marketing start
2020-06-12
Substance
GABAPENTIN
Active strength
100 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
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310432, 310434

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
72189-109-30GABAPENTIN30 in 1 BOTTLECAPSULE3015
72189-109-60GABAPENTIN60 in 1 BOTTLECAPSULE6015
72189-109-72GABAPENTIN120 in 1 BOTTLECAPSULE12015
72189-109-90GABAPENTIN90 in 1 BOTTLECAPSULE9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-109-30EA - Each72189-10994fce2d2-d41c-40c5-acd2-cecad773d36312020-07-13
72189-109-60EA - Each72189-109624bbbea-3f3e-466b-bb18-28d0d347115212020-08-06
72189-109-72EA - Each72189-109e30dd54e-76d3-45c5-ac21-44fee71678b812020-07-13
72189-109-90EA - Each72189-109b2f3d0f6-3437-48fc-863f-6efb57bbca4d12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-109GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN TABLET [DIRECT RX]15Current NDC, Legacy NDC, 4 package rows20250119_a7e45e3f-e382-32ba-e053-2a95a90a2537.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310432gabapentin 400 MG Oral CapsulePSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletPSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310430gabapentin 100 MG Oral CapsuleSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310432gabapentin 400 MG Oral CapsuleSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletSCDa7e45e3f-e382-32ba-e053-2a95a90a253715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-109-307218901093030 CAPSULE in 1 BOTTLE (72189-109-30) 30 capsule2020-06-120000-00-00NoNoCurrent
72189-109-607218901096060 CAPSULE in 1 BOTTLE (72189-109-60) 60 capsule2020-06-120000-00-00NoNoCurrent
72189-109-7272189010972120 CAPSULE in 1 BOTTLE (72189-109-72) 120 capsule2020-06-120000-00-00NoNoCurrent
72189-109-907218901099090 CAPSULE in 1 BOTTLE (72189-109-90) 90 capsule2020-06-120000-00-00NoNoCurrent