Betamethasone Dipropionate

Product NDC: 52565-019
Requested package NDC: 52565-019-15
11-digit product format: 525650019
Labeler code: 52565
Product ID: 52565-019_0f582800-bd39-4e95-b38e-26f69729d505
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: betamethasone dipropionate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Teligent Pharma, Inc.
Application: ANDA206118
Marketing category: ANDA
Marketing start: 2017-10-30
Marketing end: 0000-00-00
Substance: BETAMETHASONE DIPROPIONATE
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#

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	52565-019	52565-019-15	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 5 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52565-019	52565-019-15	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52565-019	52565-019-15	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52565-019	52565-019-15	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52565-019	52565-019-15	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52565-019	52565-019-15	I	Inactivated by FDA	excluded / ndc_excluded.zip	`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
A206118-001	BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL			2017-11-09

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL		2017-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206118-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2017-11-09	`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	A206118-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206118-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206118-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206118-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206118-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206118-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206118-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206118-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206118-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206118-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206118-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206118-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206118-001	AB	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A206118-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206118-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206118-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206118-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206118-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206118-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dde7b902-54a1-627e-12f1-9e6d244ab88c	Product name	4	20250317
69b49899-11cf-4f7e-bd0a-7dc93b27311b	Product name	3	20250130
bbdc14c7-d940-43b5-a2f7-36c425991f3c	Product name	1	20240320
0a2fcc35-464b-9ec2-a622-753662cdd48c	Product name	3	20240216
6f762601-17ef-4321-8f47-77783d3c4d8b	Product name	3	20231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70	Product name	5	20220921
7fea2046-07a9-4bb6-9409-828ac6f1f6df	Product name	1	20210201
f059f1a2-0e64-4839-9a7f-42687c91a44b	Product name	1	20201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405d	Product name	1	20160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
4f07db9b-3707-3e2c-05b5-d7852ba808c4	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52565-019-15	2023-01-30	C162847	48780-1	f386c649-e560-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment. BETAMETHASONE DIPROPIONATE Ointment USP, (Augmented) 0.05% for topical use Initial U.S. Approval: 1983
52565-019-51	2023-01-30	C162847	48780-1	f386c649-e560-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Ointment safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Ointment. BETAMETHASONE DIPROPIONATE Ointment USP, (Augmented) 0.05% for topical use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52565-019-15	Betamethasone Dipropionate	1 in 1 CARTON	OINTMENT	1	5
52565-019-15	Betamethasone Dipropionate	15 g in 1 TUBE	OINTMENT	15	5
52565-019-51	Betamethasone Dipropionate	1 in 1 CARTON	OINTMENT	1	5
52565-019-51	Betamethasone Dipropionate	50 g in 1 TUBE	OINTMENT	50	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52565-019-15	GM - Gram	52565-019	414395c0-e2d2-4b06-9f9d-8d7a2331da05	1	2018-07-03
52565-019-51	GM - Gram	52565-019	69a6638c-63d1-4c52-8ff0-0c3b7e7528b5	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52565-019	BETAMETHASONE DIPROPIONATE (BETAMETHASONE DIPROPIONATE) OINTMENT [TELIGENT PHARMA, INC.]	5	Legacy NDC, 4 package rows	20191012_b1c3c530-6e28-4fba-9a9d-5fac9819e3e6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
826Y60901U	BETAMETHASONE DIPROPIONATE	5593-20-4	BETAMETHASONE DIPROPIONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
848180	betamethasone dipropionate 0.05 % Augmented Topical Ointment	PSN	b1c3c530-6e28-4fba-9a9d-5fac9819e3e6	5
848180	Augmented betamethasone 0.0005 MG/MG Topical Ointment	SCD	b1c3c530-6e28-4fba-9a9d-5fac9819e3e6	5
848180	augmented betamethasone 0.05 % Topical Ointment	SY	b1c3c530-6e28-4fba-9a9d-5fac9819e3e6	5
848180	betamethasone 0.05 % Augmented Topical Ointment	SY	b1c3c530-6e28-4fba-9a9d-5fac9819e3e6	5
848180	betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Augmented Topical Ointment	SY	b1c3c530-6e28-4fba-9a9d-5fac9819e3e6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52565-019-15	52565001915	1 TUBE in 1 CARTON (52565-019-15) > 15 g in 1 TUBE	1 tube	2017-10-30	0000-00-00	No	No	Current