Impoyz

Product NDC: 69482-700
11-digit product format: 694820700
Labeler code: 69482
Product ID: 69482-700_0f65b721-00dd-42f1-b7c9-ad4aeebf8b94
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clobetasol propionate
Dosage form: CREAM
Route: TOPICAL
Labeler: Encore Dermatology, Inc
Application: NDA209483
Marketing category: NDA
Marketing start: 2018-01-12
Marketing end: 0000-00-00
Substance: CLOBETASOL PROPIONATE
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69482-700		D	Discontinued by firm		2026-08-07
excluded package	package	69482-700	69482-700-99	D	Discontinued by firm		2026-08-07

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69482-700-99	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69482-700-99	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69482-700-99	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69482-700-99	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69482-700-99	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69482-700-99	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69482-700-99	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69482-700-99	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69482-700-99	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69482-700-99	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69482-700-99	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69482-700-99	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69482-700-99	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69482-700-99	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69482-700-99	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
N209483-001	IMPOYZ	CLOBETASOL PROPIONATE	0.025%	CREAM / TOPICAL		RLD, RS	2017-11-28

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209483-001	10064875	2030-08-31	U-1408	Drug product	2018-09-10
N209483-001	10064875	2030-08-31	U-1858	Drug product	2018-09-10
N209483-001	10064875	2030-08-31	U-193	Drug product	2018-09-10
N209483-001	10064875	2030-08-31	U-742	Drug product	2018-09-10
N209483-001	10064875	2030-08-31	U-88	Drug product	2018-09-10
N209483-001	10588914	2030-08-31	U-2771	Drug product	2020-04-08
N209483-001	11179465	2030-08-31	U-1858	Drug product	2026-03-03
N209483-001	9956231	2030-08-31	U-1408	Drug product	2018-05-21
N209483-001	9956231	2030-08-31	U-1761	Drug product	2018-05-21
N209483-001	9956231	2030-08-31	U-1858	Drug product	2018-05-21
N209483-001	9956231	2030-08-31	U-193	Drug product	2018-05-21
N209483-001	9956231	2030-08-31	U-742	Drug product	2018-05-21
N209483-001	9956231	2030-08-31	U-88	Drug product	2018-05-21
N209483-001	9855334	2035-03-11		Drug product	2018-01-04

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209483-001	IMPOYZ	0.025%	CREAM / TOPICAL	RLD, RS	2017-11-28	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 530 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209483-001	10064875	2030-08-31	U-88	Drug product	2018-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209483-001	10064875	2030-08-31	U-1858	Drug product	2018-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209483-001	10064875	2030-08-31	U-193	Drug product	2018-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209483-001	10064875	2030-08-31	U-1408	Drug product	2018-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209483-001	10064875	2030-08-31	U-742	Drug product	2018-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209483-001	10588914	2030-08-31	U-2771	Drug product	2020-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209483-001	9956231	2030-08-31	U-88	Drug product	2018-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209483-001	9956231	2030-08-31	U-1408	Drug product	2018-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209483-001	9956231	2030-08-31	U-193	Drug product	2018-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209483-001	9956231	2030-08-31	U-742	Drug product	2018-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209483-001	9956231	2030-08-31	U-1858	Drug product	2018-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209483-001	9956231	2030-08-31	U-1761	Drug product	2018-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209483-001	9855334	2035-03-11		Drug product	2018-01-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209483-001	10064875	2030-08-31	U-88	Drug product	2018-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209483-001	10064875	2030-08-31	U-1858	Drug product	2018-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209483-001	10064875	2030-08-31	U-193	Drug product	2018-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209483-001	10064875	2030-08-31	U-1408	Drug product	2018-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209483-001	10064875	2030-08-31	U-742	Drug product	2018-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209483-001	10588914	2030-08-31	U-2771	Drug product	2020-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209483-001	9956231	2030-08-31	U-88	Drug product	2018-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209483-001	9956231	2030-08-31	U-1408	Drug product	2018-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209483-001	9956231	2030-08-31	U-193	Drug product	2018-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209483-001	9956231	2030-08-31	U-742	Drug product	2018-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209483-001	9956231	2030-08-31	U-1858	Drug product	2018-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209483-001	9956231	2030-08-31	U-1761	Drug product	2018-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209483-001	9855334	2035-03-11		Drug product	2018-01-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209483-001	10064875	2030-08-31	U-88	Drug product	2018-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209483-001	10064875	2030-08-31	U-1858	Drug product	2018-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209483-001	10064875	2030-08-31	U-193	Drug product	2018-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209483-001	10064875	2030-08-31	U-1408	Drug product	2018-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209483-001	10064875	2030-08-31	U-742	Drug product	2018-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209483-001	10588914	2030-08-31	U-2771	Drug product	2020-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209483-001	9956231	2030-08-31	U-88	Drug product	2018-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209483-001	9956231	2030-08-31	U-1408	Drug product	2018-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209483-001	9956231	2030-08-31	U-193	Drug product	2018-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209483-001	9956231	2030-08-31	U-742	Drug product	2018-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209483-001	9956231	2030-08-31	U-1858	Drug product	2018-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209483-001	9956231	2030-08-31	U-1761	Drug product	2018-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209483-001	9855334	2035-03-11		Drug product	2018-01-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209483-001	10064875	2030-08-31	U-88	Drug product	2018-09-10	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N209483-001	NP	2020-11-28	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N209483-001	NP	2020-11-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209483-001	NP	2020-11-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209483-001	NP	2020-11-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209483-001	NP	2020-11-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209483-001	NP	2020-11-28	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69482-700-99	2025-02-13	C162847	48780-1	f386c649-a1dd-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use IMPOYZ® Cream safely and effectively. See full prescribing information for IMPOYZ Cream. IMPOYZ (clobetasol propionate) Cream, 0.025%, for topical use Initial U.S. Approval: 1985
69482-700-99	2023-01-30	C162847	48780-1	f386c649-a1dd-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use IMPOYZ® Cream safely and effectively. See full prescribing information for IMPOYZ Cream. IMPOYZ (clobetasol propionate) Cream, 0.025%, for topical use Initial U.S. Approval: 1985

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69482-700-60	GM - Gram	69482-700	94a7d9e7-e3e4-45d3-bdfa-0f4f4368fdf3	1	2018-02-20
69482-700-99	GM - Gram	69482-700	f50485f4-1fa8-49d9-bcd3-2d4bce62ab7a	1	2019-12-10

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate	CLOBETASOL PROPIONATE	INA Pharmaceutics Inc	1b0e9eb5-71eb-44b4-894a-094a9f325dc8	2025-02-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209483 application number: NDA209483
Impoyz	CLOBETASOL PROPIONATE	Primus Pharmaceuticals, Inc.	40173654-334e-4618-847b-6a1e030cd2fd	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209483 application number: NDA209483

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
779619577M	CLOBETASOL PROPIONATE	25122-46-7	CLOBETASOL PROPIONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69482-700-66	69482070066	1 TUBE in 1 CARTON (69482-700-66) > 100 g in 1 TUBE (69482-700-99)	1 tube	2018-01-12	0000-00-00	No	No	Current
69482-700-99	69482070099	1 TUBE in 1 CARTON (69482-700-99) > 100 g in 1 TUBE	1 tube	2018-01-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Impoyz	Encore Dermatology, Inc \| Symbiotec Pharmalab Private Limited	2021-03-24	HUMAN PRESCRIPTION DRUG LABEL	4