Home NDC 45802-436 TAZAROTENE
Product NDC 45802-436
11-digit product format 458020436
Labeler code 45802
Product ID 45802-436_710d0db0-54af-49fd-b2ed-77582a4b3238
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tazarotene
Dosage form GEL
Route TOPICAL
Labeler Padagis Israel Pharmaceuticals Ltd
Application ANDA213079
Marketing category ANDA
Marketing start 2023-06-05
Substance TAZAROTENE
Active strength .5 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 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 A213079-001 TAZAROTENE TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 A213079-002 TAZAROTENE TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25
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 2 · 46 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 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213079-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2023-04-25 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213079-002 TAZAROTENE 0.1% GEL / TOPICAL AB 2023-04-25 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 46 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TAZAROTENE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAZAROTENE .5 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45802-436-01 TAZAROTENE 1 in 1 CARTON GEL 1 3 45802-436-01 TAZAROTENE 100 g in 1 TUBE GEL 100 3 45802-436-94 TAZAROTENE 1 in 1 CARTON GEL 1 3 45802-436-94 TAZAROTENE 30 g in 1 TUBE GEL 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45802-436 TAZAROTENE GEL [PADAGIS ISRAEL PHARMACEUTICALS LTD] 3 Current NDC, 4 package rows 20240518_ffd11dee-4266-4201-9573-1e82c2d30a63.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 45802-436-01 45802043601 1 TUBE in 1 CARTON (45802-436-01) / 100 g in 1 TUBE 1 tube 2023-06-05 No No Current 45802-436-94 45802043694 1 TUBE in 1 CARTON (45802-436-94) / 30 g in 1 TUBE 1 tube 2023-06-05 No No Current