FDA.reportPublic FDA data

Pregabalin

Product NDC
71610-998
11-digit product format
716100998
Labeler code
71610
Product ID
71610-998_4ddf7975-b00f-8c4b-e063-6394a90acb59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA208677
Marketing category
ANDA
Marketing start
2025-12-10
Substance
PREGABALIN
Active strength
150 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pregabalin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483440

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-998-30Pregabalin30 in 1 BOTTLECAPSULE301
71610-998-46Pregabalin56 in 1 BOTTLECAPSULE561
71610-998-53Pregabalin60 in 1 BOTTLECAPSULE601
71610-998-54Pregabalin84 in 1 BOTTLECAPSULE841
71610-998-70Pregabalin120 in 1 BOTTLECAPSULE1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-998-30EA - Each71610-9985b1aaed4-505c-46a5-afb5-5496355d2e4412026-05-22
71610-998-46EA - Each71610-9984d5c3fbf-c6f1-4a79-ba32-926ff925640512026-05-22
71610-998-53EA - Each71610-9982843bd86-197b-4119-98e4-262557b1134d12026-05-22
71610-998-54EA - Each71610-9985925006c-cfcd-4a19-ba9f-77123f2e082d12026-05-22
71610-998-70EA - Each71610-998b7bd2b9a-555c-4f44-919b-9bda684fa1b912026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483440pregabalin 150 MG Oral CapsulePSN4ddf7b9b-7b72-913c-e063-6394a90af3a41
483440pregabalin 150 MG Oral CapsuleSCD4ddf7b9b-7b72-913c-e063-6394a90af3a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-998-307161009983030 CAPSULE in 1 BOTTLE (71610-998-30) 30 capsule2026-03-25NoNoHistorical
71610-998-467161009984656 CAPSULE in 1 BOTTLE (71610-998-46) 56 capsule2026-03-25NoNoHistorical
71610-998-537161009985360 CAPSULE in 1 BOTTLE (71610-998-53) 60 capsule2026-03-25NoNoHistorical
71610-998-547161009985484 CAPSULE in 1 BOTTLE (71610-998-54) 84 capsule2026-03-25NoNoHistorical
71610-998-7071610099870120 CAPSULE in 1 BOTTLE (71610-998-70) 120 capsule2026-03-25NoNoHistorical