Home NDC 60758-556 Tazarotene
Product NDC 60758-556
11-digit product format 607580556
Labeler code 60758
Product ID 60758-556_7566de65-94c0-484d-9e05-812f06775077
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tazarotene
Dosage form CREAM
Route TOPICAL
Labeler Pacific Pharma, Inc.
Application NDA021184
Marketing category NDA
Marketing start 2017-04-15
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021184-001 TAZORAC TAZAROTENE 0.05% CREAM / TOPICAL AB RLD, RS 2000-09-29 N021184-002 TAZORAC TAZAROTENE 0.1% CREAM / TOPICAL AB RLD, RS 2000-09-29 N021184-003 AVAGE TAZAROTENE 0.1% CREAM / TOPICAL AB RLD, RS 2002-09-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 N021184-001 TAZORAC 0.05% CREAM / TOPICAL AB RLD, RS 2000-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021184-002 TAZORAC 0.1% CREAM / TOPICAL AB RLD, RS 2000-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021184-003 AVAGE 0.1% CREAM / TOPICAL AB RLD, RS 2002-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021184-001 TAZORAC 0.05% CREAM / TOPICAL AB RLD, RS 2000-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021184-002 TAZORAC 0.1% CREAM / TOPICAL AB RLD, RS 2000-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021184-003 AVAGE 0.1% CREAM / TOPICAL AB RLD, RS 2002-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021184-001 TAZORAC 0.05% CREAM / TOPICAL AB RLD, RS 2000-09-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021184-002 TAZORAC 0.1% CREAM / TOPICAL AB RLD, RS 2000-09-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021184-003 AVAGE 0.1% CREAM / TOPICAL AB RLD, RS 2002-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021184-001 TAZORAC 0.05% CREAM / TOPICAL AB RLD, RS 2000-09-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021184-002 TAZORAC 0.1% CREAM / TOPICAL AB RLD, RS 2000-09-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021184-003 AVAGE 0.1% CREAM / TOPICAL AB RLD, RS 2002-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021184-001 TAZORAC 0.05% CREAM / TOPICAL AB RLD, RS 2000-09-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021184-002 TAZORAC 0.1% CREAM / TOPICAL AB RLD, RS 2000-09-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021184-003 AVAGE 0.1% CREAM / TOPICAL AB RLD, RS 2002-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021184-001 TAZORAC 0.05% CREAM / TOPICAL AB RLD, RS 2000-09-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021184-002 TAZORAC 0.1% CREAM / TOPICAL AB RLD, RS 2000-09-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021184-003 AVAGE 0.1% CREAM / TOPICAL AB RLD, RS 2002-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021184-001 TAZORAC 0.05% CREAM / TOPICAL AB RLD, RS 2000-09-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021184-002 TAZORAC 0.1% CREAM / TOPICAL AB RLD, RS 2000-09-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021184-003 AVAGE 0.1% CREAM / TOPICAL AB RLD, RS 2002-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021184-001 TAZORAC 0.05% CREAM / TOPICAL AB RLD, RS 2000-09-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021184-002 TAZORAC 0.1% CREAM / TOPICAL AB RLD, RS 2000-09-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021184-003 AVAGE 0.1% CREAM / TOPICAL AB RLD, RS 2002-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021184-001 TAZORAC 0.05% CREAM / TOPICAL AB RLD, RS 2000-09-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021184-002 TAZORAC 0.1% CREAM / TOPICAL AB RLD, RS 2000-09-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021184-003 AVAGE 0.1% CREAM / TOPICAL AB RLD, RS 2002-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021184-001 TAZORAC 0.05% CREAM / TOPICAL AB RLD, RS 2000-09-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021184-002 TAZORAC 0.1% CREAM / TOPICAL AB RLD, RS 2000-09-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021184-003 AVAGE 0.1% CREAM / TOPICAL AB RLD, RS 2002-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021184-001 TAZORAC 0.05% CREAM / TOPICAL AB RLD, RS 2000-09-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021184-002 TAZORAC 0.1% CREAM / TOPICAL AB RLD, RS 2000-09-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021184-003 AVAGE 0.1% CREAM / TOPICAL AB RLD, RS 2002-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021184-001 TAZORAC 0.05% CREAM / TOPICAL AB RLD, RS 2000-09-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021184-002 TAZORAC 0.1% CREAM / TOPICAL AB RLD, RS 2000-09-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021184-003 AVAGE 0.1% CREAM / TOPICAL AB RLD, RS 2002-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021184-001 TAZORAC 0.05% CREAM / TOPICAL RLD, RS 2000-09-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021184-002 TAZORAC 0.1% CREAM / TOPICAL AB RLD, RS 2000-09-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021184-003 AVAGE 0.1% CREAM / TOPICAL AB RLD, RS 2002-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021184-001 TAZORAC 0.05% CREAM / TOPICAL RLD, RS 2000-09-29 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 97 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 60758-556-30 2023-02-03 These highlights do not include all the information needed to use tazarotene c ream safely and effectively. See full prescribing information for tazarotene c ream. T azarotene c ream , 0.05% and 0.1%, for topical use Initial U.S. Approval: 1997 60758-556-60 2023-02-03 These highlights do not include all the information needed to use tazarotene c ream safely and effectively. See full prescribing information for tazarotene c ream. T azarotene c ream , 0.05% and 0.1%, for topical use Initial U.S. Approval: 1997 60758-556-30 2023-01-30 These highlights do not include all the information needed to use tazarotene c ream safely and effectively. See full prescribing information for tazarotene c ream. T azarotene c ream , 0.05% and 0.1%, for topical use Initial U.S. Approval: 1997 60758-556-60 2023-01-30 These highlights do not include all the information needed to use tazarotene c ream safely and effectively. See full prescribing information for tazarotene c ream. T azarotene c ream , 0.05% and 0.1%, for topical use Initial U.S. Approval: 1997
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60758-556 TAZAROTENE CREAM [PACIFIC PHARMA, INC.] 5 Legacy NDC 20240921_ec939e5d-275b-4e1f-bdd1-dcfe8e5bab2b.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 60758-556-30 60758055630 30 g in 1 TUBE (60758-556-30) 30 g 2017-04-15 0000-00-00 No No Current 60758-556-60 60758055660 60 g in 1 TUBE (60758-556-60) 60 g 2017-04-15 0000-00-00 No No Current