GABAPENTIN

Product NDC
71610-621
11-digit product format
716100621
Labeler code
71610
Product ID
71610-621_bc931d95-28ae-405b-ad93-e1fe0b51eab9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA214957
Marketing category
ANDA
Marketing start
2021-10-01
Substance
GABAPENTIN
Active strength
600 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
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
71610-621-15GABAPENTIN15 in 1 BOTTLETABLET152
71610-621-30GABAPENTIN30 in 1 BOTTLETABLET302
71610-621-45GABAPENTIN45 in 1 BOTTLETABLET452
71610-621-53GABAPENTIN60 in 1 BOTTLETABLET602
71610-621-60GABAPENTIN90 in 1 BOTTLETABLET902
71610-621-70GABAPENTIN120 in 1 BOTTLETABLET1202
71610-621-73GABAPENTIN135 in 1 BOTTLETABLET1352
71610-621-80GABAPENTIN180 in 1 BOTTLETABLET1802
71610-621-92GABAPENTIN270 in 1 BOTTLETABLET2702
71610-621-94GABAPENTIN360 in 1 BOTTLETABLET3602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-621-15EA - Each71610-621184da3fb-cb48-444e-9d11-41dad6fe05d412022-04-06
71610-621-30EA - Each71610-621a505c27b-dc28-4c35-8c62-a4358829476412022-02-07
71610-621-45EA - Each71610-62139890082-48c2-4552-b07a-0b96e5f271b212022-02-07
71610-621-53EA - Each71610-62147bef506-2c20-4306-8a5d-aea25826115d12022-04-06
71610-621-60EA - Each71610-621b7511c9c-7e2d-4658-81dc-65a05b34dcb812022-02-07
71610-621-70EA - Each71610-621393d02df-efd7-40fd-9c40-aef5c78e62f612022-04-06
71610-621-73EA - Each71610-621570c0127-8df4-4680-8639-006e56cdcbd912022-02-07
71610-621-80EA - Each71610-6213bd040c5-6c52-4840-ac27-6c2ad5dc5fb012022-02-07
71610-621-92EA - Each71610-621840653d5-c973-459f-a92c-b785dffb14a412022-02-07
71610-621-94EA - Each71610-62117be1f09-0444-452e-9773-20672d48728212022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-621GABAPENTIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 10 package rows20220302_7f579665-afb7-4227-98c1-2eafee650504.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN7f579665-afb7-4227-98c1-2eafee6505042
310433gabapentin 600 MG Oral TabletSCD7f579665-afb7-4227-98c1-2eafee6505042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-621-157161006211515 TABLET in 1 BOTTLE (71610-621-15) 15 tablet2022-01-240000-00-00NoNoCurrent
71610-621-307161006213030 TABLET in 1 BOTTLE (71610-621-30) 30 tablet2021-12-020000-00-00NoNoCurrent
71610-621-457161006214545 TABLET in 1 BOTTLE (71610-621-45) 45 tablet2021-12-020000-00-00NoNoCurrent
71610-621-537161006215360 TABLET in 1 BOTTLE (71610-621-53) 60 tablet2022-01-240000-00-00NoNoCurrent
71610-621-607161006216090 TABLET in 1 BOTTLE (71610-621-60) 90 tablet2021-12-020000-00-00NoNoCurrent
71610-621-7071610062170120 TABLET in 1 BOTTLE (71610-621-70) 120 tablet2022-01-240000-00-00NoNoCurrent
71610-621-7371610062173135 TABLET in 1 BOTTLE (71610-621-73) 135 tablet2021-12-020000-00-00NoNoCurrent
71610-621-8071610062180180 TABLET in 1 BOTTLE (71610-621-80) 180 tablet2021-12-170000-00-00NoNoCurrent
71610-621-9271610062192270 TABLET in 1 BOTTLE (71610-621-92) 270 tablet2021-12-020000-00-00NoNoCurrent
71610-621-9471610062194360 TABLET in 1 BOTTLE (71610-621-94) 360 tablet2022-01-240000-00-00NoNoCurrent