FDA.reportPublic FDA data

GABAPENTIN

Product NDC
70010-109
11-digit product format
700100109
Labeler code
70010
Product ID
70010-109_44f3f3fb-7803-2bc9-e063-6394a90acefe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA075360
Marketing category
ANDA
Marketing start
2020-09-07
Substance
GABAPENTIN
Active strength
300 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
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70010-109-01GABAPENTIN100 in 1 BOTTLECAPSULE1004
70010-109-05GABAPENTIN500 in 1 BOTTLECAPSULE5004
70010-109-10GABAPENTIN1000 in 1 BOTTLECAPSULE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-109-01EA - Each70010-1091e4d7900-076f-4d6a-9352-e1349b021b6112021-01-08
70010-109-05EA - Each70010-109c28b0521-33dd-40dc-8c73-7a486a97e73b12021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-109GABAPENTIN CAPSULE [GRANULES PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 3 package rows20230217_b20ee34a-7f2d-4d62-a161-898565f74547.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN13640281-26b4-402e-8f69-7c81cd6e0376104
310431gabapentin 300 MG Oral CapsulePSN397fd6d3-317b-4b61-a52b-3a09ca1d88a4104
310431gabapentin 300 MG Oral CapsuleSCD13640281-26b4-402e-8f69-7c81cd6e0376104
310431gabapentin 300 MG Oral CapsuleSCD397fd6d3-317b-4b61-a52b-3a09ca1d88a4104
310430gabapentin 100 MG Oral CapsulePSNb20ee34a-7f2d-4d62-a161-898565f745474
310431gabapentin 300 MG Oral CapsulePSNb20ee34a-7f2d-4d62-a161-898565f745474
310432gabapentin 400 MG Oral CapsulePSNb20ee34a-7f2d-4d62-a161-898565f745474
310430gabapentin 100 MG Oral CapsuleSCDb20ee34a-7f2d-4d62-a161-898565f745474
310431gabapentin 300 MG Oral CapsuleSCDb20ee34a-7f2d-4d62-a161-898565f745474
310432gabapentin 400 MG Oral CapsuleSCDb20ee34a-7f2d-4d62-a161-898565f745474
310431gabapentin 300 MG Oral CapsulePSN5fb79774-c2d4-47ba-9a16-eb367d0fdcff1
310431gabapentin 300 MG Oral CapsuleSCD5fb79774-c2d4-47ba-9a16-eb367d0fdcff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70010-109-0170010010901100 CAPSULE in 1 BOTTLE (70010-109-01) 100 capsule2020-09-070000-00-00NoNoCurrent
70010-109-0570010010905500 CAPSULE in 1 BOTTLE (70010-109-05) 500 capsule2020-09-070000-00-00NoNoCurrent
70010-109-10700100109101000 CAPSULE in 1 BOTTLE (70010-109-10) 1000 capsule2020-09-070000-00-00NoNoCurrent