FDA.reportPublic FDA data

GABAPENTIN

Product NDC
50090-7388
11-digit product format
500907388
Labeler code
50090
Product ID
50090-7388_71191297-6f1b-48d3-a1c6-a5bcbeb18f0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA214956
Marketing category
ANDA
Marketing start
2021-05-10
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
50090-7388-0GABAPENTIN30 in 1 BOTTLECAPSULE303
50090-7388-1GABAPENTIN100 in 1 BOTTLECAPSULE1003
50090-7388-2GABAPENTIN90 in 1 BOTTLECAPSULE903
50090-7388-3GABAPENTIN42 in 1 BOTTLECAPSULE423

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7388-0EA - Each50090-7388b87421a4-10d1-476d-b053-69328e6f314312024-12-10
50090-7388-1EA - Each50090-73888311e36e-bbdf-46b9-83de-afd488d2931912024-12-10
50090-7388-2EA - Each50090-7388acdfb9e3-89e4-423f-94f3-bcb77331f6e612024-12-10
50090-7388-3EA - Each50090-7388fae1e3f3-b0d3-4247-9274-0011b01ec88d12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7388GABAPENTIN CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 4 package rows20241024_7ea0b220-edbb-45eb-aeb3-65283f8489a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN7ea0b220-edbb-45eb-aeb3-65283f8489a13
310430gabapentin 100 MG Oral CapsuleSCD7ea0b220-edbb-45eb-aeb3-65283f8489a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7388-05009073880030 CAPSULE in 1 BOTTLE (50090-7388-0) 30 capsule2024-10-21NoNoHistorical
50090-7388-150090738801100 CAPSULE in 1 BOTTLE (50090-7388-1) 100 capsule2024-10-21NoNoHistorical
50090-7388-25009073880290 CAPSULE in 1 BOTTLE (50090-7388-2) 90 capsule2024-10-21NoNoHistorical
50090-7388-35009073880342 CAPSULE in 1 BOTTLE (50090-7388-3) 42 capsule2024-10-21NoNoHistorical