FDA.reportPublic FDA data

Gabapentin

Product NDC
72162-1532
11-digit product format
721621532
Labeler code
72162
Product ID
72162-1532_53f03e36-4671-4010-b2cd-122ad55e7439
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
100 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
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
72162-1532-1Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE100101
72162-1532-5Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE500101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1532-1EA - Each72162-1532880fc064-681c-447b-9707-d42c39b963fe12024-03-12
72162-1532-5EA - Each72162-1532b71246d5-d981-4093-9e93-e0f3b0e3562d12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1532GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20240203_9a2658d5-9b0e-4921-b4c5-4c89f1630d69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN9a2658d5-9b0e-4921-b4c5-4c89f1630d69101
310430gabapentin 100 MG Oral CapsuleSCD9a2658d5-9b0e-4921-b4c5-4c89f1630d69101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1532-172162153201100 CAPSULE in 1 BOTTLE, PLASTIC (72162-1532-1) 100 capsule2018-08-20NoNoHistorical
72162-1532-572162153205500 CAPSULE in 1 BOTTLE, PLASTIC (72162-1532-5) 500 capsule2018-08-20NoNoHistorical