Cordran

Product NDC
16110-034
11-digit product format
161100034
Labeler code
16110
Product ID
16110-034_6655b5fb-f3b7-11eb-85b4-0800200c9a66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
flurandrenolide
Dosage form
CREAM
Route
TOPICAL
Labeler
Almirall, LLC
Application
NDA012806
Marketing category
NDA
Marketing start
2018-10-12
Marketing end
0000-00-00
Substance
FLURANDRENOLIDE
Active strength
0 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct16110-034DDiscontinued by firm2026-08-11
excluded packagepackage16110-03416110-034-12DDiscontinued by firm2026-08-11

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage16110-034-12d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16110-034-12f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16110-034-122ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16110-034-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16110-034-12cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16110-034-12cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16110-034-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16110-034-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16110-034-120efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16110-034-12ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16110-034-12367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16110-034-12557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N012806-001CORDRANFLURANDRENOLIDE0.05%OINTMENT / TOPICALRLD, Approved before 1982
N012806-002CORDRAN SPFLURANDRENOLIDE0.05%CREAM / TOPICALRLD, Approved before 1982
N012806-003CORDRAN SPFLURANDRENOLIDE0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982
N012806-004CORDRANFLURANDRENOLIDE0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD, Approved before 1982

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N012806-001CORDRAN0.05%OINTMENT / TOPICALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012806-002CORDRAN SP0.05%CREAM / TOPICALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012806-003CORDRAN SP0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N012806-004CORDRAN0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012806-001CORDRAN0.05%OINTMENT / TOPICALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012806-002CORDRAN SP0.05%CREAM / TOPICALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012806-003CORDRAN SP0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N012806-004CORDRAN0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N012806-001CORDRAN0.05%OINTMENT / TOPICALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012806-002CORDRAN SP0.05%CREAM / TOPICALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012806-003CORDRAN SP0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N012806-004CORDRAN0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N012806-001CORDRAN0.05%OINTMENT / TOPICALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N012806-002CORDRAN SP0.05%CREAM / TOPICALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N012806-003CORDRAN SP0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N012806-004CORDRAN0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N012806-001CORDRAN0.05%OINTMENT / TOPICALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N012806-002CORDRAN SP0.05%CREAM / TOPICALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N012806-003CORDRAN SP0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N012806-004CORDRAN0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N012806-001CORDRAN0.05%OINTMENT / TOPICALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N012806-002CORDRAN SP0.05%CREAM / TOPICALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N012806-003CORDRAN SP0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N012806-004CORDRAN0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N012806-001CORDRAN0.05%OINTMENT / TOPICALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N012806-002CORDRAN SP0.05%CREAM / TOPICALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N012806-003CORDRAN SP0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N012806-004CORDRAN0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N012806-001CORDRAN0.05%OINTMENT / TOPICALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N012806-002CORDRAN SP0.05%CREAM / TOPICALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N012806-003CORDRAN SP0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N012806-004CORDRAN0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N012806-001CORDRAN0.05%OINTMENT / TOPICALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N012806-002CORDRAN SP0.05%CREAM / TOPICALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N012806-003CORDRAN SP0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N012806-004CORDRAN0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N012806-001CORDRAN0.05%OINTMENT / TOPICALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N012806-002CORDRAN SP0.05%CREAM / TOPICALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N012806-003CORDRAN SP0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CREAM / TOPICALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N012806-004CORDRAN0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**OINTMENT / TOPICALRLD, Approved before 1982d06236e962d9…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N012806-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N012806-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N012806-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N012806-001AT174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N012806-002AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N012806-001AT1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N012806-002AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N012806-001AT1782e0a99824c…
2021-12-28 21:50 UTC2021-12N012806-002AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N012806-001AT187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N012806-002AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N012806-001AT15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N012806-002AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N012806-001AT18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N012806-002AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N012806-001AT1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N012806-002AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N012806-001AT13f01610625f2…
2019-12-14 00:12 UTC2019-12N012806-002AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N012806-001AT1b00525d2431f…
2019-09-15 20:21 UTC2019-09N012806-002AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N012806-001AT1ea99ee380514…
2019-07-19 19:46 UTC2019-07N012806-002AT1ea99ee380514…
2023-05-13 08:27 UTC2023-05N012806-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N012806-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N012806-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N012806-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N012806-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N012806-001AT1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16110-034-12GM - Gram16110-0345a5dd525-91cf-435f-82a5-1f3b0b668a9a12018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLURANDRENOLIDEACTIVE INGREDIENT8EUL29XUQTCORDRAN (FLURANDRENOLIDE) CREAM CORDRAN (FLURANDRENOLIDE) OINTMENT [AQUA PHARMACEUTICALS]6
FLURANDRENOLIDEACTIVE MOIETY8EUL29XUQTCORDRAN (FLURANDRENOLIDE) CREAM CORDRAN (FLURANDRENOLIDE) OINTMENT [AQUA PHARMACEUTICALS]6
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCORDRAN (FLURANDRENOLIDE) CREAM CORDRAN (FLURANDRENOLIDE) OINTMENT [AQUA PHARMACEUTICALS]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCORDRAN (FLURANDRENOLIDE) CREAM CORDRAN (FLURANDRENOLIDE) OINTMENT [AQUA PHARMACEUTICALS]6
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCORDRAN (FLURANDRENOLIDE) CREAM CORDRAN (FLURANDRENOLIDE) OINTMENT [AQUA PHARMACEUTICALS]6
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCORDRAN (FLURANDRENOLIDE) CREAM CORDRAN (FLURANDRENOLIDE) OINTMENT [AQUA PHARMACEUTICALS]6
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ICORDRAN (FLURANDRENOLIDE) CREAM CORDRAN (FLURANDRENOLIDE) OINTMENT [AQUA PHARMACEUTICALS]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CORDRAN (FLURANDRENOLIDE) CREAM CORDRAN (FLURANDRENOLIDE) OINTMENT [AQUA PHARMACEUTICALS]6
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCORDRAN (FLURANDRENOLIDE) CREAM CORDRAN (FLURANDRENOLIDE) OINTMENT [AQUA PHARMACEUTICALS]6
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ACORDRAN (FLURANDRENOLIDE) CREAM CORDRAN (FLURANDRENOLIDE) OINTMENT [AQUA PHARMACEUTICALS]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCORDRAN (FLURANDRENOLIDE) CREAM CORDRAN (FLURANDRENOLIDE) OINTMENT [AQUA PHARMACEUTICALS]6
WATERINACTIVE INGREDIENT059QF0KO0RCORDRAN (FLURANDRENOLIDE) CREAM CORDRAN (FLURANDRENOLIDE) OINTMENT [AQUA PHARMACEUTICALS]6
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FCORDRAN (FLURANDRENOLIDE) CREAM CORDRAN (FLURANDRENOLIDE) OINTMENT [AQUA PHARMACEUTICALS]6

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
CORDRANFLURANDRENOLIDEINA Pharmaceutics, Inc39c0d1e6-6816-7ae5-e063-6394a90a592e2025-07-07Adverse reactionsExact identifier
application applno (NDA): 012806
application number: NDA012806

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16110-034-12161100034121 TUBE in 1 CARTON (16110-034-12) > 120 g in 1 TUBE1 tube2018-10-120000-00-00NoNoCurrent