FDA.reportPublic FDA data

GABAPENTIN

Product NDC
71610-185
11-digit product format
716100185
Labeler code
71610
Product ID
71610-185_e1f89ae6-021d-4fcd-ad58-27f2be19fd6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090705
Marketing category
ANDA
Marketing start
2018-09-13
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], 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
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-185-30GABAPENTIN30 in 1 BOTTLECAPSULE301
71610-185-53GABAPENTIN60 in 1 BOTTLECAPSULE601
71610-185-60GABAPENTIN90 in 1 BOTTLECAPSULE901
71610-185-70GABAPENTIN120 in 1 BOTTLECAPSULE1201
71610-185-80GABAPENTIN180 in 1 BOTTLECAPSULE1801
71610-185-92GABAPENTIN270 in 1 BOTTLECAPSULE2701
71610-185-94GABAPENTIN360 in 1 BOTTLECAPSULE3601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-185-30EA - Each71610-1859d58886e-9e91-4478-85dc-720ed74f56eb12019-01-24
71610-185-53EA - Each71610-185e36b6372-ec8c-4384-b2a5-29e01afce6dc12019-01-24
71610-185-60EA - Each71610-185502028d9-d6b0-4a01-8c2e-328daf402ff012019-01-24
71610-185-70EA - Each71610-185d5ff2cd6-a7c1-49fc-987a-08791005c99812019-01-24
71610-185-80EA - Each71610-18581f5f05a-d8b4-4387-b1b2-d16432cdbd5412019-01-24
71610-185-92EA - Each71610-1855fa24405-e5ba-4c57-a073-7b8267f6561112019-01-24
71610-185-94EA - Each71610-1850d419390-2f68-4e74-baaa-1eb35eba713b12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-185GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 7 package rows20181114_a900bafb-8f49-4a01-ba7f-4fb228ec0253.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNa900bafb-8f49-4a01-ba7f-4fb228ec02531
310431gabapentin 300 MG Oral CapsuleSCDa900bafb-8f49-4a01-ba7f-4fb228ec02531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-185-307161001853030 CAPSULE in 1 BOTTLE (71610-185-30) 30 capsule2018-11-020000-00-00NoNoCurrent
71610-185-537161001855360 CAPSULE in 1 BOTTLE (71610-185-53) 60 capsule2018-11-020000-00-00NoNoCurrent
71610-185-607161001856090 CAPSULE in 1 BOTTLE (71610-185-60) 90 capsule2018-11-120000-00-00NoNoCurrent
71610-185-7071610018570120 CAPSULE in 1 BOTTLE (71610-185-70) 120 capsule2018-11-020000-00-00NoNoCurrent
71610-185-8071610018580180 CAPSULE in 1 BOTTLE (71610-185-80) 180 capsule2018-11-120000-00-00NoNoCurrent
71610-185-9271610018592270 CAPSULE in 1 BOTTLE (71610-185-92) 270 capsule2018-11-120000-00-00NoNoCurrent
71610-185-9471610018594360 CAPSULE in 1 BOTTLE (71610-185-94) 360 capsule2018-11-120000-00-00NoNoCurrent