BETAMETHASONE DIPROPIONATE

Product NDC: 52959-262
Requested package NDC: 52959-262-15
11-digit product format: 529590262
Labeler code: 52959
Product ID: 52959-262_82fd507e-927c-70e1-e053-2a91aa0ac903
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BETAMETHASONE DIPROPIONATE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA071012
Marketing category: ANDA
Marketing start: 2015-01-04
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#

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52959-262	52959-262-15	I	Inactivated by FDA		2026-08-17

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A071012-001	BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB		1987-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071012-001	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.

Product history page 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071012-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT / TOPICAL	AB	1987-02-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A071012-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071012-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071012-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071012-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071012-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071012-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071012-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071012-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071012-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071012-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071012-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071012-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071012-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071012-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071012-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071012-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071012-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071012-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071012-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071012-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071012-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071012-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071012-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071012-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071012-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071012-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071012-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071012-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071012-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071012-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071012-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071012-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071012-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071012-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071012-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071012-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071012-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071012-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071012-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071012-001	AB	1	`e64feba35796…`

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
52959-262-00	2022-01-28	C162847	48780-1	d6a99b39-ebab-a426-e053-dadaa90af4c2	0262 BETAMETHASONE DIPRO OINT
52959-262-15	2022-01-28	C162847	48780-1	d6a99b39-ebab-a426-e053-dadaa90af4c2	0262 BETAMETHASONE DIPRO OINT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-262-00	BETAMETHASONE DIPROPIONATE	45 g in 1 TUBE	OINTMENT	45		1
52959-262-15	BETAMETHASONE DIPROPIONATE	15 g in 1 TUBE	OINTMENT	15		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-262-00	GM - Gram	52959-262	15a1b702-2122-411a-b4da-84f5b8e73b37	1	2019-03-12
52959-262-15	GM - Gram	52959-262	93200fb8-7f76-4f88-b9fe-d2d74165f775	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-262	BETAMETHASONE DIPROPIONATE OINTMENT [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 2 package rows	20190301_82fd507e-927b-70e1-e053-2a91aa0ac903.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
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Actavis Pharma, Inc.	aa3f4012-7597-422d-8bcc-00102780a152	2023-02-28	Adverse reactions	Exact identifier application applno (ANDA): 071012 application number: ANDA071012

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
197405	betamethasone dipropionate 0.05 % Topical Ointment	PSN	82fd507e-927b-70e1-e053-2a91aa0ac903	1
197405	betamethasone 0.0005 MG/MG Topical Ointment	SCD	82fd507e-927b-70e1-e053-2a91aa0ac903	1
197405	betamethasone 0.05 % Topical Ointment	SY	82fd507e-927b-70e1-e053-2a91aa0ac903	1
197405	betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical Ointment	SY	82fd507e-927b-70e1-e053-2a91aa0ac903	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52959-262-15	52959026215	15 g in 1 TUBE (52959-262-15)	15 g	2015-01-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
0262 BETAMETHASONE DIPRO OINT	H.J. Harkins Company, Inc.	2019-02-28	HUMAN PRESCRIPTION DRUG LABEL	1