Pregabalin

Product NDC
60760-729
11-digit product format
607600729
Labeler code
60760
Product ID
60760-729_4e5918fe-4a7b-bfc1-e063-6394a90a12e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA207799
Marketing category
ANDA
Marketing start
2019-07-21
Substance
PREGABALIN
Active strength
200 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
PREGABALIN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483446

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
60760-729-30Pregabalin30 in 1 BOTTLE, PLASTICCAPSULE302
60760-729-60Pregabalin60 in 1 BOTTLE, PLASTICCAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-729-30EA - Each60760-7290145970c-ca44-406c-8a84-485c6ed2f03612026-05-22
60760-729-60EA - Each60760-72941cd4910-e646-49b5-9de5-8827360dfd4512025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483446pregabalin 200 MG Oral CapsulePSN3dd7930b-f544-f18b-e063-6294a90a05412
483446pregabalin 200 MG Oral CapsuleSCD3dd7930b-f544-f18b-e063-6294a90a05412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-729-306076007293030 CAPSULE in 1 BOTTLE, PLASTIC (60760-729-30) 30 capsule2026-03-31NoNoHistorical
60760-729-606076007296060 CAPSULE in 1 BOTTLE, PLASTIC (60760-729-60) 60 capsule2025-08-29NoNoHistorical