FDA.reportPublic FDA data

Gabapentin

Product NDC
67877-222
11-digit product format
678770222
Labeler code
67877
Product ID
67877-222_4a89b23c-8061-4a4f-827e-62ec74d59be5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA090858
Marketing category
ANDA
Marketing start
2011-01-29
Substance
GABAPENTIN
Active strength
100 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
GABAPENTIN100 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
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
67877-222-01Gabapentin100 in 1 BOTTLECAPSULE10036
67877-222-05Gabapentin500 in 1 BOTTLECAPSULE50036
67877-222-10Gabapentin1000 in 1 BOTTLECAPSULE100036
67877-222-38Gabapentin10 in 1 CARTONCAPSULE1036
67877-222-38Gabapentin10 in 1 BLISTER PACKCAPSULE1036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-222-01EA - Each67877-22243795a19-9711-422c-925f-86ed8ad791ce12012-07-24
67877-222-05EA - Each67877-2229bb789a1-3ec0-46c4-8b21-81d5bc86dcc112012-07-24
67877-222-10EA - Each67877-22249276db2-1dae-498c-a240-404764572f0e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-222GABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]36Current NDC, Legacy NDC, 5 package rows20250418_722de2a9-38b3-4518-b262-ba0d1346d0ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNa1006139-7dfc-4d87-a5a9-aeb380c32d24106
310430gabapentin 100 MG Oral CapsulePSN8a781649-3271-47a6-995f-50f91141a48a106
310430gabapentin 100 MG Oral CapsuleSCDa1006139-7dfc-4d87-a5a9-aeb380c32d24106
310430gabapentin 100 MG Oral CapsuleSCD8a781649-3271-47a6-995f-50f91141a48a106
310430gabapentin 100 MG Oral CapsulePSN03031adf-d36b-45ec-944e-dfce5a5de91a44
310431gabapentin 300 MG Oral CapsulePSN03031adf-d36b-45ec-944e-dfce5a5de91a44
310432gabapentin 400 MG Oral CapsulePSN03031adf-d36b-45ec-944e-dfce5a5de91a44
310430gabapentin 100 MG Oral CapsuleSCD03031adf-d36b-45ec-944e-dfce5a5de91a44
310431gabapentin 300 MG Oral CapsuleSCD03031adf-d36b-45ec-944e-dfce5a5de91a44
310432gabapentin 400 MG Oral CapsuleSCD03031adf-d36b-45ec-944e-dfce5a5de91a44
310430gabapentin 100 MG Oral CapsulePSN722de2a9-38b3-4518-b262-ba0d1346d0ba36
310431gabapentin 300 MG Oral CapsulePSN722de2a9-38b3-4518-b262-ba0d1346d0ba36
310432gabapentin 400 MG Oral CapsulePSN722de2a9-38b3-4518-b262-ba0d1346d0ba36
310430gabapentin 100 MG Oral CapsuleSCD722de2a9-38b3-4518-b262-ba0d1346d0ba36
310431gabapentin 300 MG Oral CapsuleSCD722de2a9-38b3-4518-b262-ba0d1346d0ba36
310432gabapentin 400 MG Oral CapsuleSCD722de2a9-38b3-4518-b262-ba0d1346d0ba36
310430gabapentin 100 MG Oral CapsulePSN09736975-2493-4dbc-bbe0-cc56a1fec53f15
310430gabapentin 100 MG Oral CapsuleSCD09736975-2493-4dbc-bbe0-cc56a1fec53f15
310430gabapentin 100 MG Oral CapsulePSN7652adc6-1aad-4422-b85c-0c6b11c23b7310
310430gabapentin 100 MG Oral CapsulePSN36f74fdf-0dae-47a0-a7ea-e64ac91cd88f10
310431gabapentin 300 MG Oral CapsulePSN36f74fdf-0dae-47a0-a7ea-e64ac91cd88f10
310432gabapentin 400 MG Oral CapsulePSN36f74fdf-0dae-47a0-a7ea-e64ac91cd88f10
310430gabapentin 100 MG Oral CapsuleSCD7652adc6-1aad-4422-b85c-0c6b11c23b7310
310430gabapentin 100 MG Oral CapsuleSCD36f74fdf-0dae-47a0-a7ea-e64ac91cd88f10
310431gabapentin 300 MG Oral CapsuleSCD36f74fdf-0dae-47a0-a7ea-e64ac91cd88f10
310432gabapentin 400 MG Oral CapsuleSCD36f74fdf-0dae-47a0-a7ea-e64ac91cd88f10
310430gabapentin 100 MG Oral CapsulePSNfce0c123-29d7-42bf-8c8d-8be1772e2d997
310430gabapentin 100 MG Oral CapsulePSNbbfdedd7-2baf-4bc6-be59-548a5cf217527
310431gabapentin 300 MG Oral CapsulePSNbbfdedd7-2baf-4bc6-be59-548a5cf217527
310432gabapentin 400 MG Oral CapsulePSNbbfdedd7-2baf-4bc6-be59-548a5cf217527
310430gabapentin 100 MG Oral CapsuleSCDfce0c123-29d7-42bf-8c8d-8be1772e2d997
310430gabapentin 100 MG Oral CapsuleSCDbbfdedd7-2baf-4bc6-be59-548a5cf217527
310431gabapentin 300 MG Oral CapsuleSCDbbfdedd7-2baf-4bc6-be59-548a5cf217527
310432gabapentin 400 MG Oral CapsuleSCDbbfdedd7-2baf-4bc6-be59-548a5cf217527
310430gabapentin 100 MG Oral CapsulePSNeb3ac1fa-d7ac-476f-973a-a36258e2db743
310430gabapentin 100 MG Oral CapsulePSNc979f80b-d4b1-40f7-b878-b216db5f325d3
310430gabapentin 100 MG Oral CapsulePSNafdf2bf9-9ada-4f53-bf5a-7961a32441213
310430gabapentin 100 MG Oral CapsuleSCDeb3ac1fa-d7ac-476f-973a-a36258e2db743
310430gabapentin 100 MG Oral CapsuleSCDc979f80b-d4b1-40f7-b878-b216db5f325d3
310430gabapentin 100 MG Oral CapsuleSCDafdf2bf9-9ada-4f53-bf5a-7961a32441213
310430gabapentin 100 MG Oral CapsulePSN59a01ec3-97d4-c099-e053-2a91aa0af7542
310431gabapentin 300 MG Oral CapsulePSN59a01ec3-97d4-c099-e053-2a91aa0af7542
310432gabapentin 400 MG Oral CapsulePSN59a01ec3-97d4-c099-e053-2a91aa0af7542
310430gabapentin 100 MG Oral CapsuleSCD59a01ec3-97d4-c099-e053-2a91aa0af7542
310431gabapentin 300 MG Oral CapsuleSCD59a01ec3-97d4-c099-e053-2a91aa0af7542
310432gabapentin 400 MG Oral CapsuleSCD59a01ec3-97d4-c099-e053-2a91aa0af7542
310430gabapentin 100 MG Oral CapsulePSN58764021-17fa-43f1-b97f-b1d3c6ca59de1
310430gabapentin 100 MG Oral CapsulePSN2b87248b-6703-70ac-e054-00144ff8d46c1
310430gabapentin 100 MG Oral CapsulePSN7d63c12e-fc0a-6620-e053-2a91aa0a07321
310430gabapentin 100 MG Oral CapsuleSCD58764021-17fa-43f1-b97f-b1d3c6ca59de1
310430gabapentin 100 MG Oral CapsuleSCD2b87248b-6703-70ac-e054-00144ff8d46c1
310430gabapentin 100 MG Oral CapsuleSCD7d63c12e-fc0a-6620-e053-2a91aa0a07321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-222-0167877022201100 CAPSULE in 1 BOTTLE (67877-222-01) 100 capsule2011-01-290000-00-00NoNoCurrent
67877-222-0567877022205500 CAPSULE in 1 BOTTLE (67877-222-05) 500 capsule2011-01-290000-00-00NoNoCurrent
67877-222-10678770222101000 CAPSULE in 1 BOTTLE (67877-222-10) 1000 capsule2011-01-290000-00-00NoNoCurrent
67877-222-386787702223810 BLISTER PACK in 1 CARTON (67877-222-38) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2020-03-270000-00-00NoNoCurrent