Tazorac

Product NDC
16110-042
11-digit product format
161100042
Labeler code
16110
Product ID
16110-042_7e6df473-8f69-4d67-bd06-a24f35ab0a62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tazarotene
Dosage form
GEL
Route
CUTANEOUS
Labeler
Almirall, LLC
Application
NDA020600
Marketing category
NDA
Marketing start
2020-02-21
Substance
TAZAROTENE
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAZAROTENE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii81BDR9Y8PS
Rxcui212437, 212438, 313199, 313201

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6Product name220260220
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
5993ea1b-833d-fa4b-caad-a0d477537538Product name520250305
c24b0f4e-b27e-8e2b-a129-1b5a6d72c459Product name220231128
18da2240-e326-4d63-90cd-d6bb15f662a0Product name120200604
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
a32b252c-8cd2-cc4a-c64c-4b9d3916df9eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16110-042-10Tazorac100 g in 1 TUBEGEL1004
16110-042-10Tazorac1 in 1 CARTONGEL14
16110-042-30Tazorac1 in 1 CARTONGEL14
16110-042-30Tazorac30 g in 1 TUBEGEL304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16110-042-10GM - Gram16110-042bb75e692-50dd-43fd-96c0-db4c85b91aa512020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16110-042TAZORAC (TAZAROTENE) GEL [ALMIRALL, LLC]2Current NDC, Legacy NDC, 4 package rows20240821_4e4e4b81-420e-4492-8a74-80b692a80057.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313199tazarotene 0.05 % Topical GelPSN4e4e4b81-420e-4492-8a74-80b692a800574
313201tazarotene 0.1 % Topical GelPSN4e4e4b81-420e-4492-8a74-80b692a800574
212437TAZORAC 0.05 % Topical GelPSN4e4e4b81-420e-4492-8a74-80b692a800574
212438TAZORAC 0.1 % Topical GelPSN4e4e4b81-420e-4492-8a74-80b692a800574
212437tazarotene 0.0005 MG/MG Topical Gel [Tazorac]SBD4e4e4b81-420e-4492-8a74-80b692a800574
212438tazarotene 0.001 MG/MG Topical Gel [Tazorac]SBD4e4e4b81-420e-4492-8a74-80b692a800574
313199tazarotene 0.0005 MG/MG Topical GelSCD4e4e4b81-420e-4492-8a74-80b692a800574
313201tazarotene 0.001 MG/MG Topical GelSCD4e4e4b81-420e-4492-8a74-80b692a800574
313199tazarotene 0.05 % Topical GelSY4e4e4b81-420e-4492-8a74-80b692a800574
313201tazarotene 0.1 % Topical GelSY4e4e4b81-420e-4492-8a74-80b692a800574
212437Tazorac 0.0005 MG/MG Topical GelSY4e4e4b81-420e-4492-8a74-80b692a800574
212438Tazorac 0.001 MG/MG Topical GelSY4e4e4b81-420e-4492-8a74-80b692a800574
212437Tazorac 0.05 % Topical GelSY4e4e4b81-420e-4492-8a74-80b692a800574
212438Tazorac 0.1 % Topical GelSY4e4e4b81-420e-4492-8a74-80b692a800574
212437Tazorac 0.5 MG in 1 GM Topical GelSY4e4e4b81-420e-4492-8a74-80b692a800574
212438Tazorac 1 MG in 1 GM Topical GelSY4e4e4b81-420e-4492-8a74-80b692a800574

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16110-042-10161100042101 TUBE in 1 CARTON (16110-042-10) / 100 g in 1 TUBE1 tube2020-02-210000-00-00NoNoCurrent
16110-042-30161100042301 TUBE in 1 CARTON (16110-042-30) / 30 g in 1 TUBE1 tube2020-02-210000-00-00NoNoCurrent