FDA.reportPublic FDA data

Gabapentin

Product NDC
69367-132
11-digit product format
693670132
Labeler code
69367
Product ID
69367-132_b779d072-7cc4-4fa2-9421-0e8ea96334cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-04-01
Marketing end
2026-12-01
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin

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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-132-04Gabapentin100 in 1 BOTTLECAPSULE10011
69367-132-06Gabapentin500 in 1 BOTTLECAPSULE50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-132-04EA - Each69367-132e7b80322-e1cc-4453-841b-08132cce910c12016-09-02
69367-132-06EA - Each69367-132c892791a-a8b8-474c-8e3a-f7ef333215fd12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-132GABAPENTIN CAPSULE [WESTMINSTER PHARMACEUTICALS, LLC]10Current NDC, Legacy NDC, 2 package rows20250417_2f70c496-b58c-30f5-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN2f70c496-b58c-30f5-e054-00144ff8d46c11
310431gabapentin 300 MG Oral CapsulePSN2f70c496-b58c-30f5-e054-00144ff8d46c11
310432gabapentin 400 MG Oral CapsulePSN2f70c496-b58c-30f5-e054-00144ff8d46c11
310430gabapentin 100 MG Oral CapsuleSCD2f70c496-b58c-30f5-e054-00144ff8d46c11
310431gabapentin 300 MG Oral CapsuleSCD2f70c496-b58c-30f5-e054-00144ff8d46c11
310432gabapentin 400 MG Oral CapsuleSCD2f70c496-b58c-30f5-e054-00144ff8d46c11
310430gabapentin 100 MG Oral CapsulePSN52af51ab-6543-466b-848c-13c588c987894
310431gabapentin 300 MG Oral CapsulePSN223a9216-6e07-49b9-8faf-bb4e529a6ae54
310431gabapentin 300 MG Oral CapsulePSN52af51ab-6543-466b-848c-13c588c987894
310432gabapentin 400 MG Oral CapsulePSN52af51ab-6543-466b-848c-13c588c987894
310430gabapentin 100 MG Oral CapsuleSCD52af51ab-6543-466b-848c-13c588c987894
310431gabapentin 300 MG Oral CapsuleSCD223a9216-6e07-49b9-8faf-bb4e529a6ae54
310431gabapentin 300 MG Oral CapsuleSCD52af51ab-6543-466b-848c-13c588c987894
310432gabapentin 400 MG Oral CapsuleSCD52af51ab-6543-466b-848c-13c588c987894

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-132-0469367013204100 CAPSULE in 1 BOTTLE (69367-132-04) 100 capsule2016-04-010000-00-00NoNoCurrent
69367-132-0669367013206500 CAPSULE in 1 BOTTLE (69367-132-06) 500 capsule2016-04-012026-12-01NoNoCurrent