Pimecrolimus

Product NDC
71335-2988
11-digit product format
713352988
Labeler code
71335
Product ID
71335-2988_d322797e-793d-4ad3-b13b-e57717a4e022
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pimecrolimus
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
NDA021302
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-11-26
Substance
PIMECROLIMUS
Active strength
10 mg/g
Pharmacologic classes
Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIMECROLIMUS10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7KYV510875
Rxcui562806

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f09f929d-0510-197c-5c14-108895586bd1Product name320200213

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2988-1Pimecrolimus30 g in 1 TUBECREAM30100
71335-2988-1Pimecrolimus1 in 1 CARTONCREAM1100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2988-1GM - Gram71335-29887a794839-5eb5-4c76-9ea0-b0678daf7cd212026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562806pimecrolimus 1 % Topical CreamPSNdc8708ec-16be-4c27-8a5e-bf84723408fe100
562806pimecrolimus 10 MG/ML Topical CreamSCDdc8708ec-16be-4c27-8a5e-bf84723408fe100
562806pimecrolimus 1 % Topical CreamSYdc8708ec-16be-4c27-8a5e-bf84723408fe100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2988-1713352988011 TUBE in 1 CARTON (71335-2988-1) / 30 g in 1 TUBE1 tube2025-11-10NoNoHistorical