FDA.reportPublic FDA data

Pregabalin

Product NDC
71610-618
11-digit product format
716100618
Labeler code
71610
Product ID
71610-618_d2de5bd4-13ac-4b83-8fa2-a75513e408fc
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
2019-07-19
Substance
PREGABALIN
Active strength
150 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
PREGABALIN150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483440, 483448

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
71610-618-30Pregabalin30 in 1 BOTTLECAPSULE307
71610-618-46Pregabalin56 in 1 BOTTLECAPSULE567
71610-618-53Pregabalin60 in 1 BOTTLECAPSULE607
71610-618-54Pregabalin84 in 1 BOTTLECAPSULE847
71610-618-70Pregabalin120 in 1 BOTTLECAPSULE1207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-618-30EA - Each71610-61865cfd2fb-d29b-4c80-aded-42b89fa790c912022-07-06
71610-618-46EA - Each71610-618491ccfcb-758f-4918-88a2-6df693a7619912022-07-06
71610-618-53EA - Each71610-61886ecdf3c-8668-4ffb-9d6b-9462ac4e335a12022-01-06
71610-618-54EA - Each71610-618b796f332-4df8-45c7-b9ab-eaac26086b1d12024-09-09
71610-618-70EA - Each71610-618b332b6a9-6577-4d51-ba2c-21a6b9ef2b8412022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-618PREGABALIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]7Current NDC, Legacy NDC, 5 package rows20240730_aa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483440pregabalin 150 MG Oral CapsulePSNaa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec7
483448pregabalin 50 MG Oral CapsulePSNaa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec7
483440pregabalin 150 MG Oral CapsuleSCDaa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec7
483448pregabalin 50 MG Oral CapsuleSCDaa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-618-307161006183030 CAPSULE in 1 BOTTLE (71610-618-30) 30 capsule2022-05-310000-00-00NoNoCurrent
71610-618-467161006184656 CAPSULE in 1 BOTTLE (71610-618-46) 56 capsule2022-05-310000-00-00NoNoCurrent
71610-618-537161006185360 CAPSULE in 1 BOTTLE (71610-618-53) 60 capsule2021-12-020000-00-00NoNoCurrent
71610-618-547161006185484 CAPSULE in 1 BOTTLE (71610-618-54) 84 capsule2024-07-16NoNoHistorical
71610-618-7071610061870120 CAPSULE in 1 BOTTLE (71610-618-70) 120 capsule2022-05-310000-00-00NoNoCurrent