FDA.reportPublic FDA data

Gabapentin

Product NDC
42385-980
11-digit product format
423850980
Labeler code
42385
Product ID
42385-980_7a649a0a-d3ca-48e4-af76-f9adf3fa6c4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Laurus Labs Limited
Application
ANDA217965
Marketing category
ANDA
Marketing start
2024-04-09
Substance
GABAPENTIN
Active strength
800 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432, 310433, 310434

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42385-980-01Gabapentin100 in 1 BOTTLETABLET, FILM COATED1003
42385-980-05Gabapentin500 in 1 BOTTLETABLET, FILM COATED5003
42385-980-11Gabapentin1000 in 1 BOTTLETABLET, FILM COATED10003
42385-980-30Gabapentin30 in 1 BOTTLETABLET, FILM COATED303
42385-980-72Gabapentin10 in 1 CARTONTABLET, FILM COATED103
42385-980-72Gabapentin10 in 1 BLISTER PACKTABLET, FILM COATED103
42385-980-90Gabapentin90 in 1 BOTTLETABLET, FILM COATED903
42385-980-01Gabapentin100 in 1 BOTTLETABLET, FILM COATED1002
42385-980-05Gabapentin500 in 1 BOTTLETABLET, FILM COATED5002
42385-980-11Gabapentin1000 in 1 BOTTLETABLET, FILM COATED10002
42385-980-17Gabapentin10 in 1 BLISTER PACKTABLET, FILM COATED102
42385-980-30Gabapentin30 in 1 BOTTLETABLET, FILM COATED302
42385-980-72Gabapentin10 in 1 CARTONTABLET, FILM COATED102
42385-980-90Gabapentin90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42385-980GABAPENTIN TABLET, FILM COATED [LAURUS LABS LIMITED]2Current NDC, 7 package rows20240723_63639720-7f93-46c0-848d-4c976889010d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310431gabapentin 300 MG Oral CapsulePSN07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310432gabapentin 400 MG Oral CapsulePSN07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310433gabapentin 600 MG Oral TabletPSN07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310434gabapentin 800 MG Oral TabletPSN07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310430gabapentin 100 MG Oral CapsuleSCD07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310431gabapentin 300 MG Oral CapsuleSCD07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310432gabapentin 400 MG Oral CapsuleSCD07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310433gabapentin 600 MG Oral TabletSCD07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310434gabapentin 800 MG Oral TabletSCD07aa1bcc-df05-44fa-92d4-63894e0e6cd64
310433gabapentin 600 MG Oral TabletPSN63639720-7f93-46c0-848d-4c976889010d2
310434gabapentin 800 MG Oral TabletPSN63639720-7f93-46c0-848d-4c976889010d2
310433gabapentin 600 MG Oral TabletSCD63639720-7f93-46c0-848d-4c976889010d2
310434gabapentin 800 MG Oral TabletSCD63639720-7f93-46c0-848d-4c976889010d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42385-980-0142385098001100 TABLET, FILM COATED in 1 BOTTLE (42385-980-01) 2024-04-09NoNoHistorical
42385-980-0542385098005500 TABLET, FILM COATED in 1 BOTTLE (42385-980-05) 2024-04-09NoNoHistorical
42385-980-11423850980111000 TABLET, FILM COATED in 1 BOTTLE (42385-980-11) 2024-04-09NoNoHistorical
42385-980-174238509801710 in 1 BLISTER PACKHistorical
42385-980-304238509803030 TABLET, FILM COATED in 1 BOTTLE (42385-980-30) 2024-04-09NoNoHistorical
42385-980-724238509807210 BLISTER PACK in 1 CARTON (42385-980-72) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2024-04-09NoNoHistorical
42385-980-904238509809090 TABLET, FILM COATED in 1 BOTTLE (42385-980-90) 2024-04-09NoNoHistorical