Home NDC 0023-8335 TAZORAC
Product NDC 0023-8335
11-digit product format 000238335
Labeler code 0023
Product ID 0023-8335_1160972d-e679-415b-83dd-5ca6b66b42d7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tazarotene
Dosage form GEL
Route CUTANEOUS
Labeler Allergan, Inc.
Application NDA020600
Marketing category NDA
Marketing start 1997-08-01
Marketing end 0000-00-00
Substance TAZAROTENE
Active strength 1 mg/g
Pharmacologic classes Retinoid [EPC],Retinoids [CS]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 0023-8335-10 excluded package package 0023-8335-03 excluded package package 0023-8335-15
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 84 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 2026-08-18 06:07:40 2026-07 N020600-001 TAZORAC 0.05% GEL / TOPICAL AB RLD, RS 1997-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020600-002 TAZORAC 0.1% GEL / TOPICAL AB RLD, RS 1997-06-13 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded tazarotene ACTIVE INGREDIENT 81BDR9Y8PS TAZORAC (TAZAROTENE) GEL [ALLERGAN, INC.] 6 tazarotene ACTIVE MOIETY 81BDR9Y8PS TAZORAC (TAZAROTENE) GEL [ALLERGAN, INC.] 6 ascorbic acid INACTIVE INGREDIENT PQ6CK8PD0R TAZORAC (TAZAROTENE) GEL [ALLERGAN, INC.] 6 butylated hydroxyanisole INACTIVE INGREDIENT REK4960K2U TAZORAC (TAZAROTENE) GEL [ALLERGAN, INC.] 6 butylated hydroxytoluene INACTIVE INGREDIENT 1P9D0Z171K TAZORAC (TAZAROTENE) GEL [ALLERGAN, INC.] 6 CARBOMER HOMOPOLYMER TYPE B INACTIVE INGREDIENT HHT01ZNK31 TAZORAC (TAZAROTENE) GEL [ALLERGAN, INC.] 6 edetate disodium INACTIVE INGREDIENT 7FLD91C86K TAZORAC (TAZAROTENE) GEL [ALLERGAN, INC.] 6 hexylene glycol INACTIVE INGREDIENT KEH0A3F75J TAZORAC (TAZAROTENE) GEL [ALLERGAN, INC.] 6 poloxamer 407 INACTIVE INGREDIENT TUF2IVW3M2 TAZORAC (TAZAROTENE) GEL [ALLERGAN, INC.] 6 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ TAZORAC (TAZAROTENE) GEL [ALLERGAN, INC.] 6 polysorbate 40 INACTIVE INGREDIENT STI11B5A2X TAZORAC (TAZAROTENE) GEL [ALLERGAN, INC.] 6 tromethamine INACTIVE INGREDIENT 023C2WHX2V TAZORAC (TAZAROTENE) GEL [ALLERGAN, INC.] 6 water INACTIVE INGREDIENT 059QF0KO0R TAZORAC (TAZAROTENE) GEL [ALLERGAN, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0023-8335 TAZORAC (TAZAROTENE) GEL [ALLERGAN, INC.] 12 Legacy NDC 20231122_75145c21-6ef2-455a-8a67-d48ddd4181a4.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0023-8335-03 00023833503 1 TUBE in 1 CARTON (0023-8335-03) > 30 g in 1 TUBE 1 tube 1997-08-01 0000-00-00 No No Current 0023-8335-10 00023833510 1 TUBE in 1 CARTON (0023-8335-10) > 100 g in 1 TUBE 1 tube 1997-08-01 0000-00-00 No No Current 0023-8335-15 00023833515 15 TUBE in 1 CARTON (0023-8335-15) > 3.5 g in 1 TUBE 15 tube 1997-08-01 0000-00-00 No No Current