Pregabalin

Product NDC
71205-304
11-digit product format
712050304
Labeler code
71205
Product ID
71205-304_4e9f6266-1c8b-4987-b307-e35191e1b896
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208677
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
75 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
PREGABALIN75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483450

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
71205-304-30Pregabalin30 in 1 BOTTLECAPSULE304
71205-304-60Pregabalin60 in 1 BOTTLECAPSULE604
71205-304-90Pregabalin90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-304-30EA - Each71205-3044ff79946-b8c7-4f9b-952a-a03dd3f9d9a012024-06-10
71205-304-60EA - Each71205-304408cd080-0cba-457f-9ef1-49bb875a06a312019-09-05
71205-304-90EA - Each71205-3043b04bb5a-a59d-41e3-a383-012728128ddd12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-304PREGABALIN CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20220421_d58c0808-2ff9-4ce6-9c07-56f723592385.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483450pregabalin 75 MG Oral CapsulePSNd58c0808-2ff9-4ce6-9c07-56f7235923854
483450pregabalin 75 MG Oral CapsuleSCDd58c0808-2ff9-4ce6-9c07-56f7235923854

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-304-307120503043030 CAPSULE in 1 BOTTLE (71205-304-30) 30 capsule2019-08-010000-00-00NoNoCurrent
71205-304-607120503046060 CAPSULE in 1 BOTTLE (71205-304-60) 60 capsule2019-08-010000-00-00NoNoCurrent
71205-304-907120503049090 CAPSULE in 1 BOTTLE (71205-304-90) 90 capsule2019-08-010000-00-00NoNoCurrent