Gabapentin

Product NDC
21695-056
11-digit product format
216950056
Labeler code
21695
Product ID
21695-056_6f3e6391-e711-42bd-9d95-ce15d7a44ed5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA075360
Marketing category
ANDA
Marketing start
2006-08-29
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-056-00Gabapentin100 in 1 BOTTLECAPSULE1001
21695-056-30Gabapentin30 in 1 BOTTLECAPSULE301
21695-056-42Gabapentin42 in 1 BOTTLECAPSULE421
21695-056-60Gabapentin60 in 1 BOTTLECAPSULE601
21695-056-72Gabapentin120 in 1 BOTTLECAPSULE1201
21695-056-78Gabapentin180 in 1 BOTTLECAPSULE1801
21695-056-87Gabapentin270 in 1 BOTTLECAPSULE2701
21695-056-90Gabapentin90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-056-00EA - Each21695-0568d51f539-1b28-4c8f-932b-799fb3cd42fc12012-07-24
21695-056-30EA - Each21695-056745d1cce-6333-4679-9293-ecef1ab9607912012-07-24
21695-056-42EA - Each21695-056158c22f3-3e06-4838-8121-721548b50b6f12012-07-24
21695-056-60EA - Each21695-056f4506061-0566-4a10-a3d2-6c6a55fa39dd12012-07-24
21695-056-72EA - Each21695-056317101aa-0f02-4d0d-91f6-51da9ac3c43912012-07-24
21695-056-78EA - Each21695-056d0dfc996-568d-4b78-869e-56a4f8732d3a12012-07-24
21695-056-87EA - Each21695-05645a6f7e5-8f19-4670-9b49-928b5565e2df12012-07-24
21695-056-90EA - Each21695-056aaeb6ccc-63c2-4c7b-a1a0-e6b58088449912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-056GABAPENTIN (GABAPENTIN) CAPSULE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 8 package rows20100305_237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb41
310431gabapentin 300 MG Oral CapsulePSN237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb41
310432gabapentin 400 MG Oral CapsulePSN237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb41
310430gabapentin 100 MG Oral CapsuleSCD237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb41
310431gabapentin 300 MG Oral CapsuleSCD237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb41
310432gabapentin 400 MG Oral CapsuleSCD237b3a0c-8389-40e1-8fb0-1f6f4ed5bfb41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-056-0021695005600100 in 1 BOTTLEHistorical
21695-056-302169500563030 in 1 BOTTLEHistorical
21695-056-422169500564242 in 1 BOTTLEHistorical
21695-056-602169500566060 in 1 BOTTLEHistorical
21695-056-7221695005672120 in 1 BOTTLEHistorical
21695-056-7821695005678180 in 1 BOTTLEHistorical
21695-056-8721695005687270 in 1 BOTTLEHistorical
21695-056-902169500569090 in 1 BOTTLEHistorical