FDA.reportPublic FDA data

gabapentin

Product NDC
62756-137
11-digit product format
627560137
Labeler code
62756
Product ID
62756-137_aff50a15-df39-495f-a145-0ba59660eed8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077242
Marketing category
ANDA
Marketing start
2022-02-01
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-137-02EA - Each62756-137b0383452-0b71-4abb-9dfc-0c358f03767512012-07-24
62756-137-04EA - Each62756-13708cf8f96-6266-40e6-a187-5e56722141c612022-07-06
62756-137-05EA - Each62756-137364218be-db3f-4894-9f56-f556d4b7d73a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
ALCOHOLINACTIVE INGREDIENT3K9958V90MGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
AMMONIAINACTIVE INGREDIENT5138Q19F1XGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
CALCIUM SULFATE DIHYDRATEINACTIVE INGREDIENT4846Q921YMGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]10
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [DIRECT RX]2
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [DIRECT RX]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MGABAPENTIN CAPSULE [DIRECT RX]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XGABAPENTIN CAPSULE [DIRECT RX]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3GABAPENTIN CAPSULE [DIRECT RX]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKGABAPENTIN CAPSULE [DIRECT RX]2
CALCIUM SULFATE DIHYDRATEINACTIVE INGREDIENT4846Q921YMGABAPENTIN CAPSULE [DIRECT RX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE [DIRECT RX]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [DIRECT RX]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN CAPSULE [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [DIRECT RX]2
GLYCERYL BEHENATEINACTIVE INGREDIENTR8WTH25YS2GABAPENTIN CAPSULE [DIRECT RX]2
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2GABAPENTIN CAPSULE [DIRECT RX]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302GABAPENTIN CAPSULE [DIRECT RX]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TGABAPENTIN CAPSULE [DIRECT RX]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN CAPSULE [DIRECT RX]2
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN CAPSULE [DIRECT RX]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [DIRECT RX]2
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN CAPSULE [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-137GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]26Current NDC, Legacy NDC20250529_c9a05f0c-b5f0-422c-9d67-6d0efc921a74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN52e49778-03f1-43cb-b75d-6c1adbb96ec62
310431gabapentin 300 MG Oral CapsulePSN52e49778-03f1-43cb-b75d-6c1adbb96ec62
310432gabapentin 400 MG Oral CapsulePSN52e49778-03f1-43cb-b75d-6c1adbb96ec62
310430gabapentin 100 MG Oral CapsuleSCD52e49778-03f1-43cb-b75d-6c1adbb96ec62
310431gabapentin 300 MG Oral CapsuleSCD52e49778-03f1-43cb-b75d-6c1adbb96ec62
310432gabapentin 400 MG Oral CapsuleSCD52e49778-03f1-43cb-b75d-6c1adbb96ec62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-137-016275601370150 CAPSULE in 1 BOX, UNIT-DOSE (62756-137-01) 50 capsule2022-02-010000-00-00NoNoCurrent
62756-137-0262756013702100 CAPSULE in 1 BOTTLE (62756-137-02) 100 capsule2022-02-010000-00-00NoNoCurrent
62756-137-0362756013703100 CAPSULE in 1 BOTTLE (62756-137-03) 100 capsule2022-02-010000-00-00NoNoCurrent
62756-137-04627560137041000 CAPSULE in 1 BOTTLE (62756-137-04) 1000 capsule2022-02-010000-00-00NoNoCurrent
62756-137-0562756013705500 CAPSULE in 1 BOTTLE (62756-137-05) 500 capsule2022-02-010000-00-00NoNoCurrent