FDA.reportPublic FDA data

Gabapentin

Product NDC
65862-200
11-digit product format
658620200
Labeler code
65862
Product ID
65862-200_7a45ad84-02a4-442d-8401-1a1495d084fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078787
Marketing category
ANDA
Marketing start
2008-01-31
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
65862-200-01Gabapentin100 in 1 BOTTLECAPSULE10028
65862-200-05Gabapentin500 in 1 BOTTLECAPSULE50028
65862-200-10Gabapentin10 in 1 CARTONCAPSULE1028
65862-200-10Gabapentin10 in 1 BLISTER PACKCAPSULE1028
65862-200-27Gabapentin270 in 1 BOTTLECAPSULE27028
65862-200-90Gabapentin90 in 1 BOTTLECAPSULE9028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-200-01EA - Each65862-20088bfb718-8fcf-4ec5-a23a-89e1179dda3d12012-07-24
65862-200-05EA - Each65862-200c257d7bf-abae-4fd6-b453-3c153b62a4e012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [AUROBINDO PHARMA LIMITED]12
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [AUROBINDO PHARMA LIMITED]12
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE [AUROBINDO PHARMA LIMITED]12
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [AUROBINDO PHARMA LIMITED]12
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN CAPSULE [AUROBINDO PHARMA LIMITED]12
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [AUROBINDO PHARMA LIMITED]12
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN CAPSULE [AUROBINDO PHARMA LIMITED]12
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [AUROBINDO PHARMA LIMITED]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [AUROBINDO PHARMA LIMITED]12
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [AUROBINDO PHARMA LIMITED]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [AUROBINDO PHARMA LIMITED]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-200GABAPENTIN CAPSULE [AUROBINDO PHARMA LIMITED]28Current NDC, Legacy NDC, 6 package rows20250524_1a619a14-0b63-4cba-80e7-474c9a1c90b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN1a619a14-0b63-4cba-80e7-474c9a1c90b928
310431gabapentin 300 MG Oral CapsulePSN1a619a14-0b63-4cba-80e7-474c9a1c90b928
310432gabapentin 400 MG Oral CapsulePSN1a619a14-0b63-4cba-80e7-474c9a1c90b928
310430gabapentin 100 MG Oral CapsuleSCD1a619a14-0b63-4cba-80e7-474c9a1c90b928
310431gabapentin 300 MG Oral CapsuleSCD1a619a14-0b63-4cba-80e7-474c9a1c90b928
310432gabapentin 400 MG Oral CapsuleSCD1a619a14-0b63-4cba-80e7-474c9a1c90b928
310432gabapentin 400 MG Oral CapsulePSNbc1316b6-1fc4-4990-95a8-4898817728761
310432gabapentin 400 MG Oral CapsulePSNefb86e22-5a84-4b33-aad0-71dd5a2c6c8f1
310432gabapentin 400 MG Oral CapsuleSCDbc1316b6-1fc4-4990-95a8-4898817728761
310432gabapentin 400 MG Oral CapsuleSCDefb86e22-5a84-4b33-aad0-71dd5a2c6c8f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-200-0165862020001100 CAPSULE in 1 BOTTLE (65862-200-01) 100 capsule2008-01-310000-00-00NoNoCurrent
65862-200-0565862020005500 CAPSULE in 1 BOTTLE (65862-200-05) 500 capsule2008-01-310000-00-00NoNoCurrent
65862-200-106586202001010 BLISTER PACK in 1 CARTON (65862-200-10) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2008-01-310000-00-00NoNoCurrent
65862-200-15658620200151500 CAPSULE in 1 BAG (65862-200-15)1500 capsule31-JAN-08Current
65862-200-2765862020027270 CAPSULE in 1 BOTTLE (65862-200-27) 270 capsule2021-04-290000-00-00NoNoCurrent
65862-200-906586202009090 CAPSULE in 1 BOTTLE (65862-200-90) 90 capsule2021-04-290000-00-00NoNoCurrent