FDA.reportPublic FDA data

Gabapentin

Product NDC
72162-1533
11-digit product format
721621533
Labeler code
72162
Product ID
72162-1533_a0a4b11c-7c4e-410a-960e-37a68045026b
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1533-1Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE100101
72162-1533-5Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE500101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1533-1EA - Each72162-15330fd90414-9e50-45b1-85f4-a40c2c8c9dfa12024-03-12
72162-1533-5EA - Each72162-1533c809dc97-55bc-4c36-b0a5-a9c7de7164a112024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1533GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20240203_1af098ad-28b5-463f-8efa-24d70a77d64c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN1af098ad-28b5-463f-8efa-24d70a77d64c101
310431gabapentin 300 MG Oral CapsuleSCD1af098ad-28b5-463f-8efa-24d70a77d64c101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1533-172162153301100 CAPSULE in 1 BOTTLE, PLASTIC (72162-1533-1) 100 capsule2018-08-20NoNoHistorical
72162-1533-572162153305500 CAPSULE in 1 BOTTLE, PLASTIC (72162-1533-5) 500 capsule2018-08-20NoNoHistorical