FDA.reportPublic FDA data

GABAPENTIN

Product NDC
49483-607
11-digit product format
494830607
Labeler code
49483
Product ID
49483-607_39a5daea-e195-c00b-e063-6394a90a42a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
TIME CAP LABORATORIES, INC
Application
ANDA090007
Marketing category
ANDA
Marketing start
2015-12-30
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN400 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49483-607-01GABAPENTIN100 in 1 BOTTLECAPSULE10010
49483-607-10GABAPENTIN1000 in 1 BOTTLECAPSULE100010
49483-607-50GABAPENTIN500 in 1 BOTTLECAPSULE50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-607-01EA - Each49483-607eb970281-cd52-4169-aca1-b9bd9a199b3212016-05-16
49483-607-10EA - Each49483-6079f6ecc9f-cc58-487c-8575-3e1c94a4072f12021-06-02
49483-607-50EA - Each49483-607f8a18fb2-a6fb-49c3-9f9b-6a71e4d1f42c12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-607GABAPENTIN CAPSULE GABAPENTIN CAPSULE [TIME CAP LABORATORIES, INC]9Current NDC, Legacy NDC, 3 package rows20241013_08880902-bd44-41b6-866b-2cbad4c3f2b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310432gabapentin 400 MG Oral CapsulePSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletPSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310430gabapentin 100 MG Oral CapsuleSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310432gabapentin 400 MG Oral CapsuleSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310430gabapentin 100 MG Oral CapsulePSN08880902-bd44-41b6-866b-2cbad4c3f2b110
310431gabapentin 300 MG Oral CapsulePSN08880902-bd44-41b6-866b-2cbad4c3f2b110
310432gabapentin 400 MG Oral CapsulePSN08880902-bd44-41b6-866b-2cbad4c3f2b110
310430gabapentin 100 MG Oral CapsuleSCD08880902-bd44-41b6-866b-2cbad4c3f2b110
310431gabapentin 300 MG Oral CapsuleSCD08880902-bd44-41b6-866b-2cbad4c3f2b110
310432gabapentin 400 MG Oral CapsuleSCD08880902-bd44-41b6-866b-2cbad4c3f2b110
310432gabapentin 400 MG Oral CapsulePSN915cee37-536c-4761-bdb9-b96c7ee0f9564
310432gabapentin 400 MG Oral CapsuleSCD915cee37-536c-4761-bdb9-b96c7ee0f9564
310432gabapentin 400 MG Oral CapsulePSNb552a38a-5ada-4e79-a5ed-c785dcf5b5683
310432gabapentin 400 MG Oral CapsuleSCDb552a38a-5ada-4e79-a5ed-c785dcf5b5683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49483-607-0149483060701100 CAPSULE in 1 BOTTLE (49483-607-01) 100 capsule2015-12-300000-00-00NoNoCurrent
49483-607-10494830607101000 CAPSULE in 1 BOTTLE (49483-607-10) 1000 capsule2021-04-170000-00-00NoNoCurrent
49483-607-5049483060750500 CAPSULE in 1 BOTTLE (49483-607-50) 500 capsule2015-12-300000-00-00NoNoCurrent