FABIOR

Product NDC
51862-295
Requested package NDC
51862-295-50
11-digit product format
518620295
Labeler code
51862
Product ID
51862-295_4c23641b-0092-4d63-e063-6394a90aa62e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tazarotene
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Mayne Pharma
Application
NDA202428
Marketing category
NDA
Marketing start
2017-03-10
Substance
TAZAROTENE
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51862-29551862-295-50DDiscontinued by firm2026-08-03

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N202428-001FABIORTAZAROTENE0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N202428-001105688592030-02-24U-2760Drug product2020-03-25
N202428-001106880712030-02-24U-2760Drug product2020-07-08
N202428-00188087162030-02-24Drug product2014-08-20

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-1187673890dc5c…
2021-03-12 10:30 UTC2021-03N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-113f01610625f2…
2019-09-15 20:21 UTC2019-09N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11b00525d2431f…
2019-07-19 19:46 UTC2019-07N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-113f0d92c62455…
2023-05-13 08:27 UTC2023-05N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11053a50430f4f…
2023-01-26 05:58 UTC2023-01N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N202428-001FABIOR0.1%AEROSOL, FOAM / TOPICALRLD, RS2012-05-11cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 3 · 115 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N202428-001105688592030-02-24U-2760Drug product2020-03-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202428-001106880712030-02-24U-2760Drug product2020-07-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202428-00188087162030-02-24Drug product2014-08-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202428-001105688592030-02-24U-2760Drug product2020-03-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202428-001106880712030-02-24U-2760Drug product2020-07-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202428-00188087162030-02-24Drug product2014-08-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N202428-001105688592030-02-24U-2760Drug product2020-03-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202428-001106880712030-02-24U-2760Drug product2020-07-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202428-00188087162030-02-24Drug product2014-08-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202428-001105688592030-02-24U-2760Drug product2020-03-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202428-001106880712030-02-24U-2760Drug product2020-07-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202428-00188087162030-02-24Drug product2014-08-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202428-001105688592030-02-24U-2760Drug product2020-03-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202428-001106880712030-02-24U-2760Drug product2020-07-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202428-00188087162030-02-24Drug product2014-08-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202428-001105688592030-02-24U-2760Drug product2020-03-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202428-001106880712030-02-24U-2760Drug product2020-07-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202428-00188087162030-02-24Drug product2014-08-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202428-001105688592030-02-24U-2760Drug product2020-03-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202428-001106880712030-02-24U-2760Drug product2020-07-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202428-00188087162030-02-24Drug product2014-08-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202428-001105688592030-02-24U-2760Drug product2020-03-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202428-001106880712030-02-24U-2760Drug product2020-07-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202428-00188087162030-02-24Drug product2014-08-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202428-001105688592030-02-24U-2760Drug product2020-03-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202428-001106880712030-02-24U-2760Drug product2020-07-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202428-00188087162030-02-24Drug product2014-08-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202428-001105688592030-02-24U-2760Drug product2020-03-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N202428-001106880712030-02-24U-2760Drug product2020-07-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N202428-00188087162030-02-24Drug product2014-08-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202428-001105688592030-02-24U-2760Drug product2020-03-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202428-001106880712030-02-24U-2760Drug product2020-07-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202428-00188087162030-02-24Drug product2014-08-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202428-001105688592030-02-24U-2760Drug product2020-03-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202428-001106880712030-02-24U-2760Drug product2020-07-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202428-00188087162030-02-24Drug product2014-08-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202428-001105688592030-02-24U-2760Drug product2020-03-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202428-001106880712030-02-24U-2760Drug product2020-07-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202428-00188087162030-02-24Drug product2014-08-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202428-001105688592030-02-24U-2760Drug product2020-03-258072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
FABIOR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAZAROTENE1 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
1293451Internal RxNorm lookup
1293456Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae0afed7-1d60-45fd-a08b-8db094618521Available 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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
18da2240-e326-4d63-90cd-d6bb15f662a0Product name120200604
a32b252c-8cd2-cc4a-c64c-4b9d3916df9eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51862-295-10FABIOR1 in 1 CARTONAEROSOL, FOAM17
51862-295-10FABIOR100 g in 1 CANAEROSOL, FOAM1007
51862-295-50FABIOR50 g in 1 CANAEROSOL, FOAM507
51862-295-50FABIOR1 in 1 CARTONAEROSOL, FOAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-295-10GM - Gram51862-295436da915-ce0b-40e6-a10d-c92446d56e8d12017-04-05
51862-295-50GM - Gram51862-2958891b29a-6330-4e7d-8c54-ba458f88414812017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-295FABIOR (TAZAROTENE) AEROSOL, FOAM [MAYNE PHARMA]5Current NDC, Legacy NDC, 4 package rows20240511_ae0afed7-1d60-45fd-a08b-8db094618521.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FABIORTAZAROTENEMayne Pharmaae0afed7-1d60-45fd-a08b-8db0946185212026-03-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 202428
application number: NDA202428
ndc (package): 51862-295-50
ndc (product): 51862-295
ndc11 (package): 51862029550
tazaroteneTAZAROTENEMayne Pharma Inc.0e337598-f589-483f-a2ae-be7c319d74542024-06-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 202428
application number: NDA202428

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293456Fabior 0.1 % Topical FoamPSNae0afed7-1d60-45fd-a08b-8db0946185217
1293451tazarotene 0.1 % Topical FoamPSNae0afed7-1d60-45fd-a08b-8db0946185217
1293456tazarotene 1 MG/ML Topical Foam [Fabior]SBDae0afed7-1d60-45fd-a08b-8db0946185217
1293451tazarotene 1 MG/ML Topical FoamSCDae0afed7-1d60-45fd-a08b-8db0946185217
1293456Fabior 0.1 % Topical FoamSYae0afed7-1d60-45fd-a08b-8db0946185217
1293456Fabior 1 MG/ML Topical FoamSYae0afed7-1d60-45fd-a08b-8db0946185217
1293451tazarotene 0.1 % Topical FoamSYae0afed7-1d60-45fd-a08b-8db0946185217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-295-50518620295501 CAN in 1 CARTON (51862-295-50) > 50 g in 1 CAN1 can2017-03-100000-00-00NoNoCurrent