FDA.reportPublic FDA data

Gabapentin

Product NDC
65862-199
11-digit product format
658620199
Labeler code
65862
Product ID
65862-199_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
300 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
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
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
65862-199-01Gabapentin100 in 1 BOTTLECAPSULE10028
65862-199-05Gabapentin500 in 1 BOTTLECAPSULE50028
65862-199-10Gabapentin10 in 1 BLISTER PACKCAPSULE1028
65862-199-10Gabapentin10 in 1 CARTONCAPSULE1028
65862-199-18Gabapentin180 in 1 BOTTLECAPSULE18028
65862-199-27Gabapentin270 in 1 BOTTLECAPSULE27028
65862-199-30Gabapentin30 in 1 BOTTLECAPSULE3028
65862-199-60Gabapentin60 in 1 BOTTLECAPSULE6028
65862-199-90Gabapentin90 in 1 BOTTLECAPSULE9028
65862-199-99Gabapentin1000 in 1 BOTTLECAPSULE100028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-199-01EA - Each65862-199aecc9215-897d-44b5-af43-a9ce1727e08b12012-07-24
65862-199-05EA - Each65862-199f720f27c-e97b-4877-b17d-b0bc54303f9312012-07-24
65862-199-99EA - Each65862-19980a8c317-ac3d-4628-ab81-c3389763aab412012-07-24

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
65862-199GABAPENTIN CAPSULE [AUROBINDO PHARMA LIMITED]28Current NDC, Legacy NDC, 10 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
310431gabapentin 300 MG Oral CapsulePSNded42b88-94dd-462d-bcdf-7fd34d1e49c35
310431gabapentin 300 MG Oral CapsuleSCDded42b88-94dd-462d-bcdf-7fd34d1e49c35
310431gabapentin 300 MG Oral CapsulePSN3b4395f2-9440-4b67-97cc-5d16f3bdd05e2
310431gabapentin 300 MG Oral CapsuleSCD3b4395f2-9440-4b67-97cc-5d16f3bdd05e2
310431gabapentin 300 MG Oral CapsulePSN344d67fa-092e-4e71-b96a-25c71bfa6bb11
310431gabapentin 300 MG Oral CapsulePSNeaf5e41e-8ed3-404e-84e0-392bebdbc0b71
310431gabapentin 300 MG Oral CapsuleSCD344d67fa-092e-4e71-b96a-25c71bfa6bb11
310431gabapentin 300 MG Oral CapsuleSCDeaf5e41e-8ed3-404e-84e0-392bebdbc0b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-199-0165862019901100 CAPSULE in 1 BOTTLE (65862-199-01) 100 capsule2008-01-310000-00-00NoNoCurrent
65862-199-0565862019905500 CAPSULE in 1 BOTTLE (65862-199-05) 500 capsule2008-01-310000-00-00NoNoCurrent
65862-199-106586201991010 BLISTER PACK in 1 CARTON (65862-199-10) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2008-01-310000-00-00NoNoCurrent
65862-199-1865862019918180 CAPSULE in 1 BOTTLE (65862-199-18) 180 capsule2021-04-290000-00-00NoNoCurrent
65862-199-26658620199262000 CAPSULE in 1 BAG (65862-199-26)2000 capsule31-JAN-08Current
65862-199-2765862019927270 CAPSULE in 1 BOTTLE (65862-199-27) 270 capsule2021-04-290000-00-00NoNoCurrent
65862-199-306586201993030 CAPSULE in 1 BOTTLE (65862-199-30) 30 capsule2021-04-290000-00-00NoNoCurrent
65862-199-606586201996060 CAPSULE in 1 BOTTLE (65862-199-60) 60 capsule2021-04-290000-00-00NoNoCurrent
65862-199-906586201999090 CAPSULE in 1 BOTTLE (65862-199-90) 90 capsule2021-04-290000-00-00NoNoCurrent
65862-199-99658620199991000 CAPSULE in 1 BOTTLE (65862-199-99) 1000 capsule2008-01-310000-00-00NoNoCurrent