FDA.reportPublic FDA data

GABAPENTIN

Product NDC
71610-088
11-digit product format
716100088
Labeler code
71610
Product ID
71610-088_0515dc32-e7fc-4208-9677-ec9dfad018f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090007
Marketing category
ANDA
Marketing start
2015-12-30
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
71610-088-53GABAPENTIN60 in 1 BOTTLECAPSULE601
71610-088-60GABAPENTIN90 in 1 BOTTLECAPSULE901
71610-088-80GABAPENTIN180 in 1 BOTTLECAPSULE1801
71610-088-92GABAPENTIN270 in 1 BOTTLECAPSULE2701
71610-088-94GABAPENTIN360 in 1 BOTTLECAPSULE3601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-088-53EA - Each71610-088b0f1fee5-920b-43c0-bfd0-ebe7c50d84db12018-09-05
71610-088-60EA - Each71610-08881079a2d-741b-4c36-9435-ec4e7a199bb012018-09-05
71610-088-80EA - Each71610-088a806d1dc-0ff4-40f4-b072-e7309fe7f1e912018-09-05
71610-088-92EA - Each71610-0887c9a8696-dd93-4930-a4f5-77be29bef17212018-09-05
71610-088-94EA - Each71610-0889d6cc3e8-8057-4053-b181-be7c5f0f5a4312018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-088GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 5 package rows20180718_9d1b9121-c25a-4d28-91c5-5fc72f1167f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN9d1b9121-c25a-4d28-91c5-5fc72f1167f41
310431gabapentin 300 MG Oral CapsuleSCD9d1b9121-c25a-4d28-91c5-5fc72f1167f41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-088-537161000885360 CAPSULE in 1 BOTTLE (71610-088-53) 60 capsule2018-06-210000-00-00NoNoCurrent
71610-088-607161000886090 CAPSULE in 1 BOTTLE (71610-088-60) 90 capsule2018-06-210000-00-00NoNoCurrent
71610-088-8071610008880180 CAPSULE in 1 BOTTLE (71610-088-80) 180 capsule2018-06-210000-00-00NoNoCurrent
71610-088-9271610008892270 CAPSULE in 1 BOTTLE (71610-088-92) 270 capsule2018-06-210000-00-00NoNoCurrent
71610-088-9471610008894360 CAPSULE in 1 BOTTLE (71610-088-94) 360 capsule2018-06-210000-00-00NoNoCurrent