TAZORAC

Product NDC
16110-916
11-digit product format
161100916
Labeler code
16110
Product ID
16110-916_ee97b76e-eb11-4165-ae85-1277eba9ff35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tazarotene
Dosage form
CREAM
Route
CUTANEOUS
Labeler
Almirall, LLC
Application
NDA021184
Marketing category
NDA
Marketing start
2020-02-03
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
TAZAROTENE.1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii81BDR9Y8PS

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6Product name220260220
5993ea1b-833d-fa4b-caad-a0d477537538Product name520250305
c24b0f4e-b27e-8e2b-a129-1b5a6d72c459Product name220231128
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
18da2240-e326-4d63-90cd-d6bb15f662a0Product name120200604
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a32b252c-8cd2-cc4a-c64c-4b9d3916df9eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16110-916-30TAZORAC30 g in 1 TUBECREAM306
16110-916-30TAZORAC1 in 1 CARTONCREAM16
16110-916-60TAZORAC60 g in 1 TUBECREAM606
16110-916-60TAZORAC1 in 1 CARTONCREAM16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16110-916-30GM - Gram16110-91637f4b08b-4b62-49fb-a1bd-0952400050cf12021-02-05
16110-916-60GM - Gram16110-9166bf801e1-9c7e-4b71-b3a6-05b8e34a5afe12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16110-916TAZORAC (TAZAROTENE) CREAM [ALMIRALL, LLC]4Current NDC, Legacy NDC, 4 package rows20240820_021744d1-a6d7-4ad6-99c2-7187c24e64c6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16110-916-30161100916301 TUBE in 1 CARTON (16110-916-30) / 30 g in 1 TUBE1 tube2020-02-030000-00-00NoNoCurrent
16110-916-60161100916601 TUBE in 1 CARTON (16110-916-60) / 60 g in 1 TUBE1 tube2020-02-030000-00-00NoNoCurrent