FDA.reportPublic FDA data

Pregabalin

Product NDC
71610-930
11-digit product format
716100930
Labeler code
71610
Product ID
71610-930_3ab511fe-2be7-d9fd-e063-6394a90ad973
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
2021-08-24
Substance
PREGABALIN
Active strength
50 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pregabalin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483448

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
71610-930-30Pregabalin30 in 1 BOTTLECAPSULE301
71610-930-46Pregabalin56 in 1 BOTTLECAPSULE561
71610-930-53Pregabalin60 in 1 BOTTLECAPSULE601
71610-930-54Pregabalin84 in 1 BOTTLECAPSULE841
71610-930-60Pregabalin90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-930-30EA - Each71610-9304c3c0603-1eba-4b68-91c5-61001fb0524512025-09-12
71610-930-46EA - Each71610-93064865579-7f6f-4af0-9c5f-f6248bb58e7c12025-09-12
71610-930-53EA - Each71610-930d422bf88-8ed8-4afe-8cbd-01d65c2923e212025-09-12
71610-930-54EA - Each71610-930a07f75f9-1a5f-4458-bd99-c4e7410346f812025-09-12
71610-930-60EA - Each71610-930cfd84f8b-836b-474f-8f8a-7bdb42c9197812025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483448pregabalin 50 MG Oral CapsulePSN3ab4efb3-1ae5-2504-e063-6294a90a6d1d1
483448pregabalin 50 MG Oral CapsuleSCD3ab4efb3-1ae5-2504-e063-6294a90a6d1d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-930-307161009303030 CAPSULE in 1 BOTTLE (71610-930-30) 30 capsule2025-07-24NoNoCurrent
71610-930-467161009304656 CAPSULE in 1 BOTTLE (71610-930-46) 56 capsule2025-07-24NoNoCurrent
71610-930-537161009305360 CAPSULE in 1 BOTTLE (71610-930-53) 60 capsule2025-07-24NoNoCurrent
71610-930-547161009305484 CAPSULE in 1 BOTTLE (71610-930-54) 84 capsule2025-07-24NoNoCurrent
71610-930-607161009306090 CAPSULE in 1 BOTTLE (71610-930-60) 90 capsule2025-07-24NoNoCurrent