Flurandrenolide

Product NDC: 51672-5301
11-digit product format: 516725301
Labeler code: 51672
Product ID: 51672-5301_35858be1-8e9a-453e-97c5-b03b80f22015
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Flurandrenolide
Dosage form: CREAM
Route: TOPICAL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
Application: NDA012806
Marketing category: NDA
Marketing start: 2016-04-25
Marketing end: 0000-00-00
Substance: FLURANDRENOLIDE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	51672-5301		D	Discontinued by firm		2026-08-11
excluded package	package	51672-5301	51672-5301-4	D	Discontinued by firm		2026-08-11

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51672-5301-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51672-5301-4	`f5e01cc5f278…`	`a2eaf40c39c3…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N012806-001	CORDRAN	FLURANDRENOLIDE	0.05%	OINTMENT / TOPICAL	RLD, Approved before 1982
N012806-002	CORDRAN SP	FLURANDRENOLIDE	0.05%	CREAM / TOPICAL	RLD, Approved before 1982
N012806-003	CORDRAN SP	FLURANDRENOLIDE	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD, Approved before 1982
N012806-004	CORDRAN	FLURANDRENOLIDE	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, 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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012806-001	CORDRAN	0.05%	OINTMENT / TOPICAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012806-002	CORDRAN SP	0.05%	CREAM / TOPICAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012806-003	CORDRAN SP	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012806-004	CORDRAN	0.025% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012806-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012806-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012806-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012806-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N012806-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012806-001	AT	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012806-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012806-001	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N012806-002	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012806-001	AT	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012806-002	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012806-001	AT	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N012806-002	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012806-001	AT	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N012806-002	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012806-001	AT	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N012806-002	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012806-001	AT	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N012806-002	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012806-001	AT	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N012806-002	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012806-001	AT	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N012806-002	AT	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	N012806-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012806-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012806-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012806-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012806-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N012806-001	AT	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-5301-4	GM - Gram	51672-5301	f4c96d4b-4041-4277-9ede-30c6bdde7eb7	1	2016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51672-5301	FLURANDRENOLIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]	1	Legacy NDC	20160430_89ff5067-af91-4d28-8ce7-8a86f8a080ab.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CORDRAN	FLURANDRENOLIDE	INA Pharmaceutics, Inc	39c0d1e6-6816-7ae5-e063-6394a90a592e	2025-07-07	Adverse reactions	Exact identifier application applno (NDA): 012806 application number: NDA012806

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8EUL29XUQT	FLURANDRENOLIDE	1524-88-5	FLURANDRENOLIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51672-5301-4	51672530104	1 TUBE in 1 CARTON (51672-5301-4) > 120 g in 1 TUBE	1 tube	2016-04-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Flurandrenolide Cream, USP	Taro Pharmaceuticals U.S.A., Inc. \| DPT Laboratories, Ltd.	2016-04-28	HUMAN PRESCRIPTION DRUG LABEL	1