FDA.reportPublic FDA data

Gabapentin

Product NDC
71610-777
11-digit product format
716100777
Labeler code
71610
Product ID
71610-777_1181743e-7065-0401-e063-6294a90afaa4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA205101
Marketing category
ANDA
Marketing start
2023-11-03
Substance
GABAPENTIN
Active strength
600 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
GABAPENTIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-777-30Gabapentin30 in 1 BOTTLETABLET304
71610-777-45Gabapentin45 in 1 BOTTLETABLET454
71610-777-53Gabapentin60 in 1 BOTTLETABLET604
71610-777-60Gabapentin90 in 1 BOTTLETABLET904
71610-777-70Gabapentin120 in 1 BOTTLETABLET1204
71610-777-73Gabapentin135 in 1 BOTTLETABLET1354
71610-777-80Gabapentin180 in 1 BOTTLETABLET1804
71610-777-92Gabapentin270 in 1 BOTTLETABLET2704

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-777-30EA - Each71610-777540d0e63-8d30-4fda-8176-a62f8d26ee2912024-03-12
71610-777-45EA - Each71610-777775150b6-c8b3-4470-bedd-1eed0a213f9a12024-03-12
71610-777-53EA - Each71610-777013865b9-e22f-465a-9614-89b06e14393412024-03-12
71610-777-60EA - Each71610-7773d22d2a7-e7b4-4503-97ea-94a3cbe77bda12024-03-12
71610-777-70EA - Each71610-7774bb6b18f-f408-4ec3-8feb-aad4411279f312024-03-12
71610-777-73EA - Each71610-777c748b4b3-5311-420a-8345-89ac0ad4926812024-03-12
71610-777-80EA - Each71610-777ab391b24-d232-428c-9374-10de15b27b8812024-03-12
71610-777-92EA - Each71610-777a8b8f0a3-9a2b-4c6c-991c-16c0bd29441e12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-777GABAPENTIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, 8 package rows20240217_7a2aa696-7dac-4d03-916a-374b61a255b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN7a2aa696-7dac-4d03-916a-374b61a255b54
310433gabapentin 600 MG Oral TabletSCD7a2aa696-7dac-4d03-916a-374b61a255b54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-777-307161007773030 TABLET in 1 BOTTLE (71610-777-30) 30 tablet2024-01-25NoNoHistorical
71610-777-457161007774545 TABLET in 1 BOTTLE (71610-777-45) 45 tablet2024-01-25NoNoHistorical
71610-777-537161007775360 TABLET in 1 BOTTLE (71610-777-53) 60 tablet2024-01-31NoNoHistorical
71610-777-607161007776090 TABLET in 1 BOTTLE (71610-777-60) 90 tablet2024-02-12NoNoHistorical
71610-777-7071610077770120 TABLET in 1 BOTTLE (71610-777-70) 120 tablet2024-02-12NoNoHistorical
71610-777-7371610077773135 TABLET in 1 BOTTLE (71610-777-73) 135 tablet2024-01-31NoNoHistorical
71610-777-8071610077780180 TABLET in 1 BOTTLE (71610-777-80) 180 tablet2024-02-12NoNoHistorical
71610-777-9271610077792270 TABLET in 1 BOTTLE (71610-777-92) 270 tablet2024-01-31NoNoHistorical