Flurandrenolide

Product NDC: 45802-928
11-digit product format: 458020928
Labeler code: 45802
Product ID: 45802-928_a5be325d-6006-40c1-bace-5adcf29548e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Flurandrenolide
Dosage form: LOTION
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA207133
Marketing category: ANDA
Marketing start: 2016-10-06
Substance: FLURANDRENOLIDE
Active strength: .5 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207133-001	FLURANDRENOLIDE	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL		RS	2016-08-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207133-001	FLURANDRENOLIDE	0.05%	LOTION / TOPICAL	AT		2016-08-30	`cb3db0bc1861…`

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	A207133-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207133-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207133-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207133-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207133-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207133-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207133-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207133-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207133-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207133-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207133-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207133-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207133-001	AT	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A207133-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207133-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207133-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207133-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207133-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207133-001	AT	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLURANDRENOLIDE	.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8EUL29XUQT	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197719	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
9c4f5aea-2e08-400c-88f6-d9e3013afda7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b046c6cd-ed10-2b40-9e85-9cb60b50fa3f	Product name	3	20170404
2ed24cee-55db-9e19-e6d2-8702f9ff1929	Product name	3	20170314
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45802-928-03	Flurandrenolide	120 mL in 1 BOTTLE, PLASTIC	LOTION	120		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-928-03	ML - Milliliter	45802-928	88c23920-3ad2-44ee-ae8a-3d7ef09166a1	1	2016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-928	FLURANDRENOLIDE LOTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]	5	Current NDC, Legacy NDC, 1 package rows	20221027_9c4f5aea-2e08-400c-88f6-d9e3013afda7.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flurandrenolide	FLURANDRENOLIDE	Bryant Ranch Prepack	2718df54-7dc1-4ebc-8258-607bedcf5813	2023-08-17	Adverse reactions	Exact identifier application applno (ANDA): 207133 application number: ANDA207133
Flurandrenolide	FLURANDRENOLIDE	Bryant Ranch Prepack	3868377d-bee3-42f4-8c72-319e84e7d5bd	2023-07-17	Adverse reactions	Exact identifier application applno (ANDA): 207133 application number: ANDA207133
Flurandrenolide	FLURANDRENOLIDE	Padagis Israel Pharmaceuticals Ltd	9c4f5aea-2e08-400c-88f6-d9e3013afda7	2022-10-11	Adverse reactions	Exact identifier application applno (ANDA): 207133 application number: ANDA207133 ndc (product): 45802-928

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197719	flurandrenolide 0.05 % Topical Lotion	PSN	3868377d-bee3-42f4-8c72-319e84e7d5bd	104
197719	flurandrenolide 0.5 MG/ML Topical Lotion	SCD	3868377d-bee3-42f4-8c72-319e84e7d5bd	104
197719	flurandrenolide 0.05 % Topical Lotion	SY	3868377d-bee3-42f4-8c72-319e84e7d5bd	104
197719	flurandrenolide 0.05 % Topical Lotion	PSN	2718df54-7dc1-4ebc-8258-607bedcf5813	100
197719	flurandrenolide 0.5 MG/ML Topical Lotion	SCD	2718df54-7dc1-4ebc-8258-607bedcf5813	100
197719	flurandrenolide 0.05 % Topical Lotion	SY	2718df54-7dc1-4ebc-8258-607bedcf5813	100
197719	flurandrenolide 0.05 % Topical Lotion	PSN	9c4f5aea-2e08-400c-88f6-d9e3013afda7	5
197719	flurandrenolide 0.5 MG/ML Topical Lotion	SCD	9c4f5aea-2e08-400c-88f6-d9e3013afda7	5
197719	flurandrenolide 0.05 % Topical Lotion	SY	9c4f5aea-2e08-400c-88f6-d9e3013afda7	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-928-03	45802092803	120 mL in 1 BOTTLE, PLASTIC (45802-928-03)	120 ml	2016-10-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Flurandrenolide Lotion USP, 0.05%	Bryant Ranch Prepack	2023-08-17	HUMAN PRESCRIPTION DRUG LABEL	100
Flurandrenolide Lotion USP, 0.05%	Bryant Ranch Prepack	2023-07-17	HUMAN PRESCRIPTION DRUG LABEL	104
Flurandrenolide Lotion USP, 0.05%	Padagis Israel Pharmaceuticals Ltd	2022-10-11	HUMAN PRESCRIPTION DRUG LABEL	5