FDA.reportPublic FDA data

Gabapentin

Product NDC
42385-974
11-digit product format
423850974
Labeler code
42385
Product ID
42385-974_7a649a0a-d3ca-48e4-af76-f9adf3fa6c4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Laurus Labs Limited
Application
ANDA217546
Marketing category
ANDA
Marketing start
2023-05-13
Substance
GABAPENTIN
Active strength
400 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
GABAPENTIN400 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
42385-974-01Gabapentin100 in 1 BOTTLECAPSULE1003
42385-974-05Gabapentin500 in 1 BOTTLECAPSULE5003
42385-974-11Gabapentin1000 in 1 BOTTLECAPSULE10003
42385-974-30Gabapentin30 in 1 BOTTLECAPSULE303
42385-974-72Gabapentin10 in 1 BLISTER PACKCAPSULE103
42385-974-72Gabapentin10 in 1 CARTONCAPSULE103
42385-974-90Gabapentin90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42385-974-01EA - Each42385-974b49043c6-b1ee-44f4-a71c-b166c86f9df112024-03-12
42385-974-05EA - Each42385-9741c14fc9f-2af5-47f9-ade1-c527af75cedb12024-03-12
42385-974-11EA - Each42385-9742edf3d63-6ee3-43ca-b16c-de18756260ef12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42385-974GABAPENTIN CAPSULE [LAURUS LABS LIMITED]2Current NDC, 7 package rows20240530_07aa1bcc-df05-44fa-92d4-63894e0e6cd6.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42385-974-0142385097401100 CAPSULE in 1 BOTTLE (42385-974-01) 100 capsule2023-05-13NoNoHistorical
42385-974-0542385097405500 CAPSULE in 1 BOTTLE (42385-974-05) 500 capsule2023-05-13NoNoHistorical
42385-974-11423850974111000 CAPSULE in 1 BOTTLE (42385-974-11) 1000 capsule2023-05-13NoNoHistorical
42385-974-304238509743030 CAPSULE in 1 BOTTLE (42385-974-30) 30 capsule2023-05-13NoNoHistorical
42385-974-724238509747210 BLISTER PACK in 1 CARTON (42385-974-72) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2023-05-13NoNoHistorical
42385-974-904238509749090 CAPSULE in 1 BOTTLE (42385-974-90) 90 capsule2023-05-13NoNoHistorical