FDA.reportPublic FDA data

Gabapentin

Product NDC
53746-103
11-digit product format
537460103
Labeler code
53746
Product ID
53746-103_10e5f9be-7920-4775-801b-e1c32b996410
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA078428
Marketing category
ANDA
Marketing start
2009-11-24
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
53746-103-01Gabapentin100 in 1 BOTTLECAPSULE10037
53746-103-05Gabapentin500 in 1 BOTTLECAPSULE50037
53746-103-10Gabapentin1000 in 1 BOTTLECAPSULE100037
53746-103-30Gabapentin30 in 1 BOTTLECAPSULE3037

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-103-01EA - Each53746-103e384933f-9392-4d88-ad18-46bfd2d14d1912012-07-24
53746-103-05EA - Each53746-103cd575883-c950-49e4-8179-7ff0c9c3524712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]26
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]26
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]8
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]8
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [PHYSICIANS TOTAL CARE, INC.]8
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [REBEL DISTRIBUTORS CORP]3
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [CONTRACT PHARMACY SERVICES-PA]2
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [UNIT DOSE SERVICES]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [UNIT DOSE SERVICES]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [CONTRACT PHARMACY SERVICES-PA]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN CAPSULE [CONTRACT PHARMACY SERVICES-PA]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [CONTRACT PHARMACY SERVICES-PA]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [CONTRACT PHARMACY SERVICES-PA]2
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [KELTMAN PHARMACEUTICALS INC.]1
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [STAT RX USA LLC]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [KELTMAN PHARMACEUTICALS INC.]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [STAT RX USA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGABAPENTIN CAPSULE [STAT RX USA LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GABAPENTIN CAPSULE [STAT RX USA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN CAPSULE [STAT RX USA LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [STAT RX USA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [STAT RX USA LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-103GABAPENTIN CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]37Current NDC, Legacy NDC, 4 package rows20240102_b11dbff5-ceee-4a63-a093-f6efebdc2f6f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNb11dbff5-ceee-4a63-a093-f6efebdc2f6f37
310431gabapentin 300 MG Oral CapsulePSNb11dbff5-ceee-4a63-a093-f6efebdc2f6f37
310432gabapentin 400 MG Oral CapsulePSNb11dbff5-ceee-4a63-a093-f6efebdc2f6f37
310430gabapentin 100 MG Oral CapsuleSCDb11dbff5-ceee-4a63-a093-f6efebdc2f6f37
310431gabapentin 300 MG Oral CapsuleSCDb11dbff5-ceee-4a63-a093-f6efebdc2f6f37
310432gabapentin 400 MG Oral CapsuleSCDb11dbff5-ceee-4a63-a093-f6efebdc2f6f37
310430gabapentin 100 MG Oral CapsulePSN7d1c0aab-5385-4d42-805c-7be2b6cdfe4b8
310431gabapentin 300 MG Oral CapsulePSN7d1c0aab-5385-4d42-805c-7be2b6cdfe4b8
310432gabapentin 400 MG Oral CapsulePSN7d1c0aab-5385-4d42-805c-7be2b6cdfe4b8
310430gabapentin 100 MG Oral CapsuleSCD7d1c0aab-5385-4d42-805c-7be2b6cdfe4b8
310431gabapentin 300 MG Oral CapsuleSCD7d1c0aab-5385-4d42-805c-7be2b6cdfe4b8
310432gabapentin 400 MG Oral CapsuleSCD7d1c0aab-5385-4d42-805c-7be2b6cdfe4b8
310432gabapentin 400 MG Oral CapsulePSN3ec0d1db-210c-4480-8cd6-2bd8603b10855
310432gabapentin 400 MG Oral CapsuleSCD3ec0d1db-210c-4480-8cd6-2bd8603b10855
310430gabapentin 100 MG Oral CapsulePSN591e0212-71ac-4f7a-b30a-8f4b745b263b3
310430gabapentin 100 MG Oral CapsulePSNcd2d3b9d-09cc-4342-9888-9b2e792a51ee3
310431gabapentin 300 MG Oral CapsulePSNcd2d3b9d-09cc-4342-9888-9b2e792a51ee3
310432gabapentin 400 MG Oral CapsulePSNcd2d3b9d-09cc-4342-9888-9b2e792a51ee3
310432gabapentin 400 MG Oral CapsulePSN591e0212-71ac-4f7a-b30a-8f4b745b263b3
310430gabapentin 100 MG Oral CapsuleSCD591e0212-71ac-4f7a-b30a-8f4b745b263b3
310430gabapentin 100 MG Oral CapsuleSCDcd2d3b9d-09cc-4342-9888-9b2e792a51ee3
310431gabapentin 300 MG Oral CapsuleSCDcd2d3b9d-09cc-4342-9888-9b2e792a51ee3
310432gabapentin 400 MG Oral CapsuleSCD591e0212-71ac-4f7a-b30a-8f4b745b263b3
310432gabapentin 400 MG Oral CapsuleSCDcd2d3b9d-09cc-4342-9888-9b2e792a51ee3
310431gabapentin 300 MG Oral CapsulePSN06f5461f-0a34-42e1-b84a-567ffafd8e992
310432gabapentin 400 MG Oral CapsulePSN06f5461f-0a34-42e1-b84a-567ffafd8e992
310431gabapentin 300 MG Oral CapsuleSCD06f5461f-0a34-42e1-b84a-567ffafd8e992
310432gabapentin 400 MG Oral CapsuleSCD06f5461f-0a34-42e1-b84a-567ffafd8e992
310430gabapentin 100 MG Oral CapsulePSNd08562ff-7ebf-4669-a824-933bf66b63281
310431gabapentin 300 MG Oral CapsulePSNd08562ff-7ebf-4669-a824-933bf66b63281
310432gabapentin 400 MG Oral CapsulePSN5bf08c96-e0fa-4f67-ba31-c28937dd48151
310432gabapentin 400 MG Oral CapsulePSNd08562ff-7ebf-4669-a824-933bf66b63281
310430gabapentin 100 MG Oral CapsuleSCDd08562ff-7ebf-4669-a824-933bf66b63281
310431gabapentin 300 MG Oral CapsuleSCDd08562ff-7ebf-4669-a824-933bf66b63281
310432gabapentin 400 MG Oral CapsuleSCD5bf08c96-e0fa-4f67-ba31-c28937dd48151
310432gabapentin 400 MG Oral CapsuleSCDd08562ff-7ebf-4669-a824-933bf66b63281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-103-0153746010301100 CAPSULE in 1 BOTTLE (53746-103-01) 100 capsule2009-11-240000-00-00NoNoCurrent
53746-103-0553746010305500 CAPSULE in 1 BOTTLE (53746-103-05) 500 capsule2009-11-240000-00-00NoNoCurrent
53746-103-10537460103101000 CAPSULE in 1 BOTTLE (53746-103-10) 1000 capsule2009-11-240000-00-00NoNoCurrent
53746-103-305374601033030 CAPSULE in 1 BOTTLE (53746-103-30) 30 capsule2009-11-240000-00-00NoNoCurrent