GABAPENTIN

Product NDC
61919-083
11-digit product format
619190083
Labeler code
61919
Product ID
61919-083_9c9437d9-bfc9-2a03-e053-2a95a90aeded
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA075350
Marketing category
ANDA
Marketing start
2019-08-08
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
400 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
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
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
61919-083-90GABAPENTIN90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-083-60EA - Each61919-08352d6158c-1422-4e15-9900-a014ce19f25812019-09-05
61919-083-72EA - Each61919-0831f4e4043-b0eb-4c0a-b0ed-a4ac067693d712019-11-12
61919-083-90EA - Each61919-08340b8291a-53e7-4837-8b07-5246a7050e4c12016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [DIRECT RX]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [DIRECT RX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGABAPENTIN CAPSULE [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGABAPENTIN CAPSULE [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [DIRECT RX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE [DIRECT RX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GABAPENTIN CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [DIRECT RX]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GABAPENTIN CAPSULE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71OGABAPENTIN CAPSULE [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GABAPENTIN CAPSULE [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [DIRECT RX]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-083GABAPENTIN CAPSULE [DIRECT RX]5Legacy NDC, 1 package rows20161025_f08849b1-a914-4e94-bbce-ebd72e785986.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSNf08849b1-a914-4e94-bbce-ebd72e7859865
310432gabapentin 400 MG Oral CapsuleSCDf08849b1-a914-4e94-bbce-ebd72e7859865

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-083-606191900836060 CAPSULE in 1 BOTTLE (61919-083-60) 60 capsule2019-08-080000-00-00NoNoCurrent
61919-083-7261919008372120 CAPSULE in 1 BOTTLE (61919-083-72) 120 capsule2019-08-080000-00-00NoNoCurrent
61919-083-906191900839090 in 1 BOTTLEHistorical