GABAPENTIN

Product NDC
70010-928
11-digit product format
700100928
Labeler code
70010
Product ID
70010-928_36bac528-54ce-1b68-e063-6394a90a0bee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc
Application
ANDA075360
Marketing category
ANDA
Marketing start
2021-09-01
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

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
70010-928-01GABAPENTIN100 in 1 BOTTLECAPSULE1007
70010-928-05GABAPENTIN500 in 1 BOTTLECAPSULE5007
70010-928-10GABAPENTIN1000 in 1 BOTTLECAPSULE10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-928-01EA - Each70010-928379a4e7e-7392-4855-902e-225858b8750e12023-02-06
70010-928-05EA - Each70010-92808c47374-f518-4e6e-b8ec-d09a554612a112023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-928GABAPENTIN CAPSULE [GRANULES PHARMACEUTICALS INC]6Current NDC, Legacy NDC, 3 package rows20241006_c681c804-c6f3-d63b-e053-2995a90a6b8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNc681c804-c6f3-d63b-e053-2995a90a6b8f7
310431gabapentin 300 MG Oral CapsulePSNc681c804-c6f3-d63b-e053-2995a90a6b8f7
310432gabapentin 400 MG Oral CapsulePSNc681c804-c6f3-d63b-e053-2995a90a6b8f7
310430gabapentin 100 MG Oral CapsuleSCDc681c804-c6f3-d63b-e053-2995a90a6b8f7
310431gabapentin 300 MG Oral CapsuleSCDc681c804-c6f3-d63b-e053-2995a90a6b8f7
310432gabapentin 400 MG Oral CapsuleSCDc681c804-c6f3-d63b-e053-2995a90a6b8f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70010-928-0170010092801100 CAPSULE in 1 BOTTLE (70010-928-01) 100 capsule2021-09-010000-00-00NoNoCurrent
70010-928-0570010092805500 CAPSULE in 1 BOTTLE (70010-928-05) 500 capsule2021-09-010000-00-00NoNoCurrent
70010-928-10700100928101000 CAPSULE in 1 BOTTLE (70010-928-10) 1000 capsule2021-09-010000-00-00NoNoCurrent