Tazarotene

Product NDC
73473-309
11-digit product format
734730309
Labeler code
73473
Product ID
73473-309_d0c2fbdf-c1f1-43de-93ef-7da5e6279875
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tazarotene
Dosage form
GEL
Route
CUTANEOUS
Labeler
Solaris Pharma Corporation
Application
ANDA213644
Marketing category
ANDA
Marketing start
2025-01-03
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213644-001TAZAROTENETAZAROTENE0.05%GEL / TOPICALAB2023-03-20
A213644-002TAZAROTENETAZAROTENE0.1%GEL / TOPICALAB2023-03-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A213644-001AB
A213644-002AB

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 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-20caaa826d4ba7…
2026-08-18 06:07:402026-07A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-208072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-206a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-201c564ffb4f44…
2024-02-18 07:12 UTC2024-02A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-20ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-20a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213644-001TAZAROTENE0.05%GEL / TOPICALAB2023-03-209b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213644-002TAZAROTENE0.1%GEL / TOPICALAB2023-03-209b2671bbb829…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A213644-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213644-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213644-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213644-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213644-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213644-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213644-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213644-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213644-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213644-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213644-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213644-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213644-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213644-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213644-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213644-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213644-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213644-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213644-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213644-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213644-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213644-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213644-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213644-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213644-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213644-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213644-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213644-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213644-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213644-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213644-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213644-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213644-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A213644-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213644-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A213644-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213644-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213644-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213644-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213644-002AB19b2671bbb829…

Additional Listing Data#

Finished product
Yes
Brand name base
Tazarotene
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAZAROTENE.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
81BDR9Y8PSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313199Internal RxNorm lookup
313201Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f1c98c4a-f101-4f3c-851a-39c827415c46Available on FDA.report

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
18da2240-e326-4d63-90cd-d6bb15f662a0Product name120200604
a32b252c-8cd2-cc4a-c64c-4b9d3916df9eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73473-309-10Tazarotene1 in 1 CARTONGEL14
73473-309-10Tazarotene100 g in 1 TUBEGEL1004
73473-309-30Tazarotene1 in 1 CARTONGEL14
73473-309-30Tazarotene30 g in 1 TUBEGEL304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73473-309TAZAROTENE GEL [SOLARIS PHARMA CORPORATION]4Current NDC, 4 package rows20250104_f1c98c4a-f101-4f3c-851a-39c827415c46.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TazaroteneTAZAROTENESolaris Pharma Corporationf1c98c4a-f101-4f3c-851a-39c827415c462025-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213644
application number: ANDA213644
ndc (product): 73473-309

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313199tazarotene 0.05 % Topical GelPSNf1c98c4a-f101-4f3c-851a-39c827415c464
313201tazarotene 0.1 % Topical GelPSNf1c98c4a-f101-4f3c-851a-39c827415c464
313199tazarotene 0.0005 MG/MG Topical GelSCDf1c98c4a-f101-4f3c-851a-39c827415c464
313201tazarotene 0.001 MG/MG Topical GelSCDf1c98c4a-f101-4f3c-851a-39c827415c464
313199tazarotene 0.05 % Topical GelSYf1c98c4a-f101-4f3c-851a-39c827415c464
313201tazarotene 0.1 % Topical GelSYf1c98c4a-f101-4f3c-851a-39c827415c464

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73473-309-10734730309101 TUBE in 1 CARTON (73473-309-10) / 100 g in 1 TUBE1 tube2025-01-03NoNoCurrent
73473-309-30734730309301 TUBE in 1 CARTON (73473-309-30) / 30 g in 1 TUBE1 tube2025-01-03NoNoCurrent