FDA.reportPublic FDA data

Gabapentin

Product NDC
71610-146
11-digit product format
716100146
Labeler code
71610
Product ID
71610-146_97600ad8-cdf2-4664-83c1-e1deecb26772
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-02-18
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-146-30Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE301
71610-146-53Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE601
71610-146-60Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE901
71610-146-70Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1201
71610-146-80Gabapentin180 in 1 BOTTLE, PLASTICCAPSULE1801
71610-146-92Gabapentin270 in 1 BOTTLE, PLASTICCAPSULE2701
71610-146-98Gabapentin540 in 1 BOTTLE, PLASTICCAPSULE5401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-146-30EA - Each71610-1467a2ba912-52c6-47bd-aac2-fb676b8120fb12018-11-06
71610-146-53EA - Each71610-146e387eb87-5770-45e5-a0ba-a879f22540d012018-11-06
71610-146-60EA - Each71610-1462ab015ae-e777-4487-9fdc-68bafd00ec6712018-11-06
71610-146-70EA - Each71610-1461efbb8d7-5a64-485b-8ff3-5ee091fa8b2612018-11-06
71610-146-80EA - Each71610-1468567db4f-c0de-4cf3-9c1f-b846ff8fcde412018-11-06
71610-146-92EA - Each71610-14683e8e140-18f9-4bfc-bd72-b1eba316957612018-11-06
71610-146-98EA - Each71610-146eb14076b-dd7c-4b9b-813c-2256a32c132312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-146GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 7 package rows20180925_1b73e9db-eddb-49ba-9778-01d39ece4d16.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN1b73e9db-eddb-49ba-9778-01d39ece4d161
310431gabapentin 300 MG Oral CapsuleSCD1b73e9db-eddb-49ba-9778-01d39ece4d161

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-146-307161001463030 CAPSULE in 1 BOTTLE, PLASTIC (71610-146-30) 30 capsule2018-09-100000-00-00NoNoCurrent
71610-146-537161001465360 CAPSULE in 1 BOTTLE, PLASTIC (71610-146-53) 60 capsule2018-09-100000-00-00NoNoCurrent
71610-146-607161001466090 CAPSULE in 1 BOTTLE, PLASTIC (71610-146-60) 90 capsule2018-09-100000-00-00NoNoCurrent
71610-146-7071610014670120 CAPSULE in 1 BOTTLE, PLASTIC (71610-146-70) 120 capsule2018-09-100000-00-00NoNoCurrent
71610-146-8071610014680180 CAPSULE in 1 BOTTLE, PLASTIC (71610-146-80) 180 capsule2018-09-100000-00-00NoNoCurrent
71610-146-9271610014692270 CAPSULE in 1 BOTTLE, PLASTIC (71610-146-92) 270 capsule2018-09-100000-00-00NoNoCurrent
71610-146-9871610014698540 CAPSULE in 1 BOTTLE, PLASTIC (71610-146-98) 540 capsule2018-09-100000-00-00NoNoCurrent