FDA.reportPublic FDA data

Gabapentin

Product NDC
71610-211
11-digit product format
716100211
Labeler code
71610
Product ID
71610-211_2b487fd0-f18e-c5c5-e063-6394a90aa1a8
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
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
71610-211-60Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE905
71610-211-70Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1205
71610-211-80Gabapentin180 in 1 BOTTLE, PLASTICCAPSULE1805
71610-211-92Gabapentin270 in 1 BOTTLE, PLASTICCAPSULE2705
71610-211-94Gabapentin360 in 1 BOTTLE, PLASTICCAPSULE3605
71610-211-98Gabapentin540 in 1 BOTTLE, PLASTICCAPSULE5405

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-211-60EA - Each71610-211bc8e56c7-805f-4739-9f75-3f5735125fea12020-07-13
71610-211-70EA - Each71610-211e80dbc35-4d5f-4858-bda0-5aaf7104c5b612020-07-13
71610-211-80EA - Each71610-211545b97f7-3188-4df3-b607-6590c930c45f12020-07-13
71610-211-92EA - Each71610-211ddc2e5aa-a6cf-453b-ae34-7c1192cc750512020-07-13
71610-211-94EA - Each71610-2119c2f7f3b-d494-48b5-90a8-75f1073b8f4f12020-07-13
71610-211-98EA - Each71610-2114b6e1a19-9f50-4704-94a5-d96464ebe27a12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-211GABAPENTIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]5Current NDC, Legacy NDC, 6 package rows20250125_41ce952c-6c16-4b5d-adf7-9ea114e63eb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN41ce952c-6c16-4b5d-adf7-9ea114e63eb35
310431gabapentin 300 MG Oral CapsuleSCD41ce952c-6c16-4b5d-adf7-9ea114e63eb35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-211-607161002116090 CAPSULE in 1 BOTTLE, PLASTIC (71610-211-60) 90 capsule2019-02-060000-00-00NoNoCurrent
71610-211-7071610021170120 CAPSULE in 1 BOTTLE, PLASTIC (71610-211-70) 120 capsule2019-02-060000-00-00NoNoCurrent
71610-211-8071610021180180 CAPSULE in 1 BOTTLE, PLASTIC (71610-211-80) 180 capsule2019-02-060000-00-00NoNoCurrent
71610-211-9271610021192270 CAPSULE in 1 BOTTLE, PLASTIC (71610-211-92) 270 capsule2020-05-050000-00-00NoNoCurrent
71610-211-9471610021194360 CAPSULE in 1 BOTTLE, PLASTIC (71610-211-94) 360 capsule2019-02-060000-00-00NoNoCurrent
71610-211-9871610021198540 CAPSULE in 1 BOTTLE, PLASTIC (71610-211-98) 540 capsule2018-12-280000-00-00NoNoCurrent