Home NDC 16110-042 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020600-001 TAZORAC TAZAROTENE 0.05% GEL / TOPICAL AB RLD, RS 1997-06-13 N020600-002 TAZORAC TAZAROTENE 0.1% GEL / TOPICAL AB RLD, RS 1997-06-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020600-001 TAZORAC 0.05% GEL / TOPICAL AB RLD, RS 1997-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020600-002 TAZORAC 0.1% GEL / TOPICAL AB RLD, RS 1997-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020600-001 TAZORAC 0.05% GEL / TOPICAL AB RLD, RS 1997-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020600-002 TAZORAC 0.1% GEL / TOPICAL AB RLD, RS 1997-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020600-001 TAZORAC 0.05% GEL / TOPICAL AB RLD, RS 1997-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020600-002 TAZORAC 0.1% GEL / TOPICAL AB RLD, RS 1997-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020600-001 TAZORAC 0.05% GEL / TOPICAL AB RLD, RS 1997-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020600-002 TAZORAC 0.1% GEL / TOPICAL AB RLD, RS 1997-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020600-001 TAZORAC 0.05% GEL / TOPICAL AB RLD, RS 1997-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020600-002 TAZORAC 0.1% GEL / TOPICAL AB RLD, RS 1997-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020600-001 TAZORAC 0.05% GEL / TOPICAL AB RLD, RS 1997-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020600-002 TAZORAC 0.1% GEL / TOPICAL AB RLD, RS 1997-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020600-001 TAZORAC 0.05% GEL / TOPICAL AB RLD, RS 1997-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020600-002 TAZORAC 0.1% GEL / TOPICAL AB RLD, RS 1997-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020600-001 TAZORAC 0.05% GEL / TOPICAL AB RLD, RS 1997-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020600-002 TAZORAC 0.1% GEL / TOPICAL AB RLD, RS 1997-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020600-001 TAZORAC 0.05% GEL / TOPICAL AB RLD, RS 1997-06-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020600-002 TAZORAC 0.1% GEL / TOPICAL AB RLD, RS 1997-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020600-001 TAZORAC 0.05% GEL / TOPICAL AB RLD, RS 1997-06-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020600-002 TAZORAC 0.1% GEL / TOPICAL AB RLD, RS 1997-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020600-001 TAZORAC 0.05% GEL / TOPICAL AB RLD, RS 1997-06-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020600-002 TAZORAC 0.1% GEL / TOPICAL AB RLD, RS 1997-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020600-001 TAZORAC 0.05% GEL / TOPICAL AB RLD, RS 1997-06-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020600-002 TAZORAC 0.1% GEL / TOPICAL AB RLD, RS 1997-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020600-001 TAZORAC 0.05% GEL / TOPICAL AB RLD, RS 1997-06-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020600-002 TAZORAC 0.1% GEL / TOPICAL AB RLD, RS 1997-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020600-001 TAZORAC 0.05% GEL / TOPICAL AB RLD, RS 1997-06-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020600-002 TAZORAC 0.1% GEL / TOPICAL AB RLD, RS 1997-06-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020600-001 TAZORAC 0.05% GEL / TOPICAL RLD, RS 1997-06-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020600-002 TAZORAC 0.1% GEL / TOPICAL RLD, RS 1997-06-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020600-001 TAZORAC 0.05% GEL / TOPICAL RLD, RS 1997-06-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020600-002 TAZORAC 0.1% GEL / TOPICAL RLD, RS 1997-06-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020600-001 TAZORAC 0.05% GEL / TOPICAL RLD, RS 1997-06-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020600-002 TAZORAC 0.1% GEL / TOPICAL RLD, RS 1997-06-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020600-001 TAZORAC 0.05% GEL / TOPICAL RLD, RS 1997-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020600-002 TAZORAC 0.1% GEL / TOPICAL RLD, RS 1997-06-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020600-001 TAZORAC 0.05% GEL / TOPICAL RLD, RS 1997-06-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020600-002 TAZORAC 0.1% GEL / TOPICAL RLD, RS 1997-06-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020600-001 TAZORAC 0.05% GEL / TOPICAL RLD, RS 1997-06-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020600-002 TAZORAC 0.1% GEL / TOPICAL RLD, RS 1997-06-13 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tazorac
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAZAROTENE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 81BDR9Y8PS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 212437 Internal RxNorm lookup 212438 Internal RxNorm lookup 313199 Internal RxNorm lookup 313201 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16110-042 TAZORAC (TAZAROTENE) GEL [ALMIRALL, LLC] 2 Current NDC, Legacy NDC, 4 package rows 20240821_4e4e4b81-420e-4492-8a74-80b692a80057.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16110-042-10 16110004210 1 TUBE in 1 CARTON (16110-042-10) / 100 g in 1 TUBE 1 tube 2020-02-21 0000-00-00 No No Current 16110-042-30 16110004230 1 TUBE in 1 CARTON (16110-042-30) / 30 g in 1 TUBE 1 tube 2020-02-21 0000-00-00 No No Current