Pregabalin

Product NDC
60687-473
11-digit product format
606870473
Labeler code
60687
Product ID
60687-473_1ac6cf05-42a1-4456-e063-6394a90a5c9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA210432
Marketing category
ANDA
Marketing start
2019-08-08
Substance
PREGABALIN
Active strength
25 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
PREGABALIN25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483438, 483440, 483442, 483448, 483450

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
60687-473-01Pregabalin100 in 1 BOX, UNIT-DOSECAPSULE1004
60687-473-11Pregabalin1 in 1 BLISTER PACKCAPSULE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-473PREGABALIN CAPSULE [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 2 package rows20240710_59da1a16-d409-49eb-9b44-397c77006043.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN59da1a16-d409-49eb-9b44-397c770060434
483440pregabalin 150 MG Oral CapsulePSN59da1a16-d409-49eb-9b44-397c770060434
483442pregabalin 25 MG Oral CapsulePSN59da1a16-d409-49eb-9b44-397c770060434
483448pregabalin 50 MG Oral CapsulePSN59da1a16-d409-49eb-9b44-397c770060434
483450pregabalin 75 MG Oral CapsulePSN59da1a16-d409-49eb-9b44-397c770060434
483438pregabalin 100 MG Oral CapsuleSCD59da1a16-d409-49eb-9b44-397c770060434
483440pregabalin 150 MG Oral CapsuleSCD59da1a16-d409-49eb-9b44-397c770060434
483442pregabalin 25 MG Oral CapsuleSCD59da1a16-d409-49eb-9b44-397c770060434
483448pregabalin 50 MG Oral CapsuleSCD59da1a16-d409-49eb-9b44-397c770060434
483450pregabalin 75 MG Oral CapsuleSCD59da1a16-d409-49eb-9b44-397c770060434

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-473-0160687047301100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-473-01) / 1 CAPSULE in 1 BLISTER PACK (60687-473-11) 100 blister pack2019-08-080000-00-00NoNoCurrent
60687-473-11606870473111 in 1 BLISTER PACKHistorical