FDA.reportPublic FDA data

Gabapentin

Product NDC
67877-224
11-digit product format
678770224
Labeler code
67877
Product ID
67877-224_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
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
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
67877-224-01Gabapentin100 in 1 BOTTLECAPSULE10036
67877-224-05Gabapentin500 in 1 BOTTLECAPSULE50036
67877-224-10Gabapentin1000 in 1 BOTTLECAPSULE100036
67877-224-38Gabapentin10 in 1 CARTONCAPSULE1036
67877-224-38Gabapentin10 in 1 BLISTER PACKCAPSULE1036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-224-01EA - Each67877-224757fdadf-31e6-413b-b6fa-ac884d34c96812012-07-24
67877-224-05EA - Each67877-22438aa9f92-bd01-4690-9c1c-66abbb01eab812012-07-24
67877-224-10EA - Each67877-2246b2433ab-7983-460d-bcb5-c75845a0410312012-07-24

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
67877-224GABAPENTIN 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
310432gabapentin 400 MG Oral CapsulePSNf0e7a6c9-ae6c-4259-81ab-a37db54e3c80105
310432gabapentin 400 MG Oral CapsulePSNeb2f6784-e7be-41b6-871b-2c3c961664ab105
310432gabapentin 400 MG Oral CapsuleSCDf0e7a6c9-ae6c-4259-81ab-a37db54e3c80105
310432gabapentin 400 MG Oral CapsuleSCDeb2f6784-e7be-41b6-871b-2c3c961664ab105
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
310432gabapentin 400 MG Oral CapsulePSN78445dbf-c7cd-419f-a7be-72821e49662819
310432gabapentin 400 MG Oral CapsuleSCD78445dbf-c7cd-419f-a7be-72821e49662819
310431gabapentin 300 MG Oral CapsulePSN517fdc6d-5e72-4ee6-8471-7a7f8f4ecfe713
310432gabapentin 400 MG Oral CapsulePSN517fdc6d-5e72-4ee6-8471-7a7f8f4ecfe713
310431gabapentin 300 MG Oral CapsuleSCD517fdc6d-5e72-4ee6-8471-7a7f8f4ecfe713
310432gabapentin 400 MG Oral CapsuleSCD517fdc6d-5e72-4ee6-8471-7a7f8f4ecfe713
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 CapsuleSCD36f74fdf-0dae-47a0-a7ea-e64ac91cd88f10
310431gabapentin 300 MG Oral CapsuleSCD36f74fdf-0dae-47a0-a7ea-e64ac91cd88f10
310432gabapentin 400 MG Oral CapsuleSCD36f74fdf-0dae-47a0-a7ea-e64ac91cd88f10
310432gabapentin 400 MG Oral CapsulePSN0c51a5dd-b3d4-44f4-b674-fa434b1357dd8
310432gabapentin 400 MG Oral CapsuleSCD0c51a5dd-b3d4-44f4-b674-fa434b1357dd8
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 CapsuleSCDbbfdedd7-2baf-4bc6-be59-548a5cf217527
310431gabapentin 300 MG Oral CapsuleSCDbbfdedd7-2baf-4bc6-be59-548a5cf217527
310432gabapentin 400 MG Oral CapsuleSCDbbfdedd7-2baf-4bc6-be59-548a5cf217527
310432gabapentin 400 MG Oral CapsulePSNc89a68b6-6dc0-4624-e053-2a95a90a687e5
310432gabapentin 400 MG Oral CapsuleSCDc89a68b6-6dc0-4624-e053-2a95a90a687e5
310430gabapentin 100 MG Oral CapsulePSN59a01ec3-97d4-c099-e053-2a91aa0af7542
310431gabapentin 300 MG Oral CapsulePSN59a01ec3-97d4-c099-e053-2a91aa0af7542
310431gabapentin 300 MG Oral CapsulePSN14b1840d-a2db-4eec-bc25-029e35b042e42
310432gabapentin 400 MG Oral CapsulePSN59a01ec3-97d4-c099-e053-2a91aa0af7542
310432gabapentin 400 MG Oral CapsulePSN176c5b60-93c2-4574-8b51-c15180912aaa2
310432gabapentin 400 MG Oral CapsulePSN14b1840d-a2db-4eec-bc25-029e35b042e42
310430gabapentin 100 MG Oral CapsuleSCD59a01ec3-97d4-c099-e053-2a91aa0af7542
310431gabapentin 300 MG Oral CapsuleSCD14b1840d-a2db-4eec-bc25-029e35b042e42
310431gabapentin 300 MG Oral CapsuleSCD59a01ec3-97d4-c099-e053-2a91aa0af7542
310432gabapentin 400 MG Oral CapsuleSCD14b1840d-a2db-4eec-bc25-029e35b042e42
310432gabapentin 400 MG Oral CapsuleSCD176c5b60-93c2-4574-8b51-c15180912aaa2
310432gabapentin 400 MG Oral CapsuleSCD59a01ec3-97d4-c099-e053-2a91aa0af7542
310432gabapentin 400 MG Oral CapsulePSN743faa18-5e7c-4fcc-9781-4157450d90c41
310432gabapentin 400 MG Oral CapsulePSN04a0c58c-dddf-462d-96e6-9317161ea4961
310432gabapentin 400 MG Oral CapsulePSN6fc8e8b2-5d0e-4c72-9a46-6d312c3efac71
310432gabapentin 400 MG Oral CapsuleSCD743faa18-5e7c-4fcc-9781-4157450d90c41
310432gabapentin 400 MG Oral CapsuleSCD6fc8e8b2-5d0e-4c72-9a46-6d312c3efac71
310432gabapentin 400 MG Oral CapsuleSCD04a0c58c-dddf-462d-96e6-9317161ea4961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-224-0167877022401100 CAPSULE in 1 BOTTLE (67877-224-01) 100 capsule2011-01-290000-00-00NoNoCurrent
67877-224-0567877022405500 CAPSULE in 1 BOTTLE (67877-224-05) 500 capsule2011-01-290000-00-00NoNoCurrent
67877-224-10678770224101000 CAPSULE in 1 BOTTLE (67877-224-10) 1000 capsule2011-01-290000-00-00NoNoCurrent
67877-224-386787702243810 BLISTER PACK in 1 CARTON (67877-224-38) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2020-03-270000-00-00NoNoCurrent