FDA.reportPublic FDA data

GABAPENTIN

Product NDC
61919-640
11-digit product format
619190640
Labeler code
61919
Product ID
61919-640_47e158f3-f67b-74b2-e063-6394a90ac498
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090007
Marketing category
ANDA
Marketing start
2015-12-30
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GABAPENTIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310431

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-640-602025-01-30C16284748780-12cef2736-6134-d83d-e063-dadaa90ab31fGABAPENTIN
61919-640-722025-01-30C16284748780-12cef2736-982a-d83d-e063-dadaa90ab31fGABAPENTIN
61919-640-822025-01-30C16284748780-12cef2736-5ff9-d83d-e063-dadaa90ab31fGABAPENTIN
61919-640-902025-01-30C16284748780-12cef2736-5ff9-d83d-e063-dadaa90ab31fGABAPENTIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-640-30GABAPENTIN30 in 1 BOTTLECAPSULE308
61919-640-82GABAPENTIN180 in 1 BOTTLECAPSULE1803
61919-640-90GABAPENTIN90 in 1 BOTTLECAPSULE903
61919-640-60GABAPENTIN60 in 1 BOTTLECAPSULE601
61919-640-72GABAPENTIN120 in 1 BOTTLECAPSULE1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-640-30EA - Each61919-640fbf6cd7f-aee9-4836-8b53-788d76eefdc812019-04-11
61919-640-60EA - Each61919-640b18973da-2799-4a50-8644-67622f83615f12019-09-05
61919-640-72EA - Each61919-6405698190b-545d-47dc-befd-635af0d3b28312019-09-05
61919-640-82EA - Each61919-640cfbbdae1-2d54-4d0f-b67b-0e43b5d0f1ec12021-05-05
61919-640-90EA - Each61919-6408a222c35-994d-49a3-a3af-94cb90b47cd412019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [DIRECT RX]4
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [DIRECT RX]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGABAPENTIN CAPSULE [DIRECT RX]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGABAPENTIN CAPSULE [DIRECT RX]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AGABAPENTIN CAPSULE [DIRECT RX]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [DIRECT RX]4
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [DIRECT RX]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [DIRECT RX]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-640GABAPENTIN CAPSULE [DIRECT RX]7Current NDC, Legacy NDC, 1 package rows20240111_29a70e2d-d3fd-4e32-95dd-7ee721d87388.zip
61919-640GABAPENTIN CAPSULE [DIRECT_RX]3Current NDC, Legacy NDC, 2 package rows20230511_907853a0-9979-62e7-e053-2995a90a5aca.zip
61919-640GABAPENTIN CAPSULE [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190810_8f9fbc86-2027-b203-e053-2a95a90af299.zip
61919-640GABAPENTIN CAPSULE [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190810_8f9fc8a2-0d10-12f1-e053-2995a90acf3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN29a70e2d-d3fd-4e32-95dd-7ee721d873888
310431gabapentin 300 MG Oral CapsuleSCD29a70e2d-d3fd-4e32-95dd-7ee721d873888
310431gabapentin 300 MG Oral CapsulePSN907853a0-9979-62e7-e053-2995a90a5aca3
310431gabapentin 300 MG Oral CapsuleSCD907853a0-9979-62e7-e053-2995a90a5aca3
310431gabapentin 300 MG Oral CapsulePSN8f9fbc86-2027-b203-e053-2a95a90af2991
310431gabapentin 300 MG Oral CapsulePSN8f9fc8a2-0d10-12f1-e053-2995a90acf3d1
310431gabapentin 300 MG Oral CapsuleSCD8f9fbc86-2027-b203-e053-2a95a90af2991
310431gabapentin 300 MG Oral CapsuleSCD8f9fc8a2-0d10-12f1-e053-2995a90acf3d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-640-306191906403030 CAPSULE in 1 BOTTLE (61919-640-30) 30 capsule2019-04-090000-00-00NoNoCurrent
61919-640-606191906406060 CAPSULE in 1 BOTTLE (61919-640-60) 60 capsule2019-08-080000-00-00NoNoCurrent
61919-640-7261919064072120 CAPSULE in 1 BOTTLE (61919-640-72) 120 capsule2019-08-080000-00-00NoNoCurrent
61919-640-8261919064082180 CAPSULE in 1 BOTTLE (61919-640-82) 180 capsule2019-08-190000-00-00NoNoCurrent
61919-640-906191906409090 CAPSULE in 1 BOTTLE (61919-640-90) 90 capsule2019-08-190000-00-00NoNoCurrent