Alclometasone Dipropionate

Product NDC: 0168-0264
Requested package NDC: 0168-0264-60
11-digit product format: 001680264
Labeler code: 0168
Product ID: 0168-0264_f4b24fb7-96bb-4c9a-b1a0-e66f909553f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alclometasone dipropionate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application: ANDA076884
Marketing category: ANDA
Marketing start: 2005-07-18
Marketing end: 0000-00-00
Substance: ALCLOMETASONE DIPROPIONATE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0168-0264	0168-0264-60	D	Discontinued by firm		2026-08-03

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
A076884-001	ALCLOMETASONE DIPROPIONATE	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A076884-001	AB

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.

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
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A076884-001	ALCLOMETASONE DIPROPIONATE	0.05%	OINTMENT / TOPICAL	AB	RS	2005-07-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076884-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076884-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076884-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076884-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076884-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076884-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076884-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076884-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076884-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076884-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076884-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076884-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076884-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076884-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076884-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076884-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076884-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076884-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076884-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076884-001	AB	1	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A076884-001	AB	1	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0168-0264-15	2020-09-03	C162847	48780-1	ab0e2407-33ee-f274-e053-dbdaa90a6471	ALCLOMETASONE DIPROPIONATE OINTMENT USP, 0.05%
0168-0264-45	2020-09-03	C162847	48780-1	ab0e2407-33ee-f274-e053-dbdaa90a6471	ALCLOMETASONE DIPROPIONATE OINTMENT USP, 0.05%
0168-0264-60	2020-09-03	C162847	48780-1	ab0e2407-33ee-f274-e053-dbdaa90a6471	ALCLOMETASONE DIPROPIONATE OINTMENT USP, 0.05%
0168-0264-15	2020-07-22	C162847	48780-1	ab0e2407-33ee-f274-e053-dbdaa90a6471	ALCLOMETASONE DIPROPIONATE OINTMENT USP, 0.05%
0168-0264-45	2020-07-22	C162847	48780-1	ab0e2407-33ee-f274-e053-dbdaa90a6471	ALCLOMETASONE DIPROPIONATE OINTMENT USP, 0.05%
0168-0264-60	2020-07-22	C162847	48780-1	ab0e2407-33ee-f274-e053-dbdaa90a6471	ALCLOMETASONE DIPROPIONATE OINTMENT USP, 0.05%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0168-0264-15	GM - Gram	0168-0264	c868d18c-8e0b-4d16-8720-f445fd717779	1	2012-07-24
0168-0264-45	GM - Gram	0168-0264	49347979-d920-4b48-975b-079e0aa58040	1	2012-07-24
0168-0264-60	GM - Gram	0168-0264	28d32605-d36f-4633-bd3f-eadb7c3bc6c5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCLOMETASONE DIPROPIONATE	ACTIVE INGREDIENT	S56PQL4N1V	ALCLOMETASONE DIPROPIONATE OINTMENT [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4
ALCLOMETASONE	ACTIVE MOIETY	136H45TB7B	ALCLOMETASONE DIPROPIONATE OINTMENT [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4
HEXYLENE GLYCOL	INACTIVE INGREDIENT	KEH0A3F75J	ALCLOMETASONE DIPROPIONATE OINTMENT [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	ALCLOMETASONE DIPROPIONATE OINTMENT [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4
PROPYLENE GLYCOL STEARATE	INACTIVE INGREDIENT	MZM1I680W0	ALCLOMETASONE DIPROPIONATE OINTMENT [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	ALCLOMETASONE DIPROPIONATE OINTMENT [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	4

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S56PQL4N1V	ALCLOMETASONE DIPROPIONATE	66734-13-2	ALCLOMETASONE DIPROPIONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0168-0264-60	00168026460	1 TUBE in 1 CARTON (0168-0264-60) > 60 g in 1 TUBE	1 tube	2005-07-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALCLOMETASONE DIPROPIONATE OINTMENT USP, 0.05%	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	2020-09-03	HUMAN PRESCRIPTION DRUG LABEL	8