Betamethasone Valerate

Product NDC: 70518-0721
11-digit product format: 705180721
Labeler code: 70518
Product ID: 70518-0721_b87d5b7d-b685-557e-e053-2995a90aaaa3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: betamethasone valerate
Dosage form: CREAM
Route: TOPICAL
Labeler: REMEDYREPACK INC.
Application: NDA018861
Marketing category: NDA
Marketing start: 2017-08-31
Marketing end: 0000-00-00
Substance: BETAMETHASONE VALERATE
Active strength: 1 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-0721		D	Discontinued by firm	2026-08-17
excluded package	package	70518-0721	70518-0721-0	D	Discontinued by firm	2026-08-17
excluded package	package	70518-0721	70518-0721-1	D	Discontinued by firm	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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0721-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-0721-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0721-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-0721-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-0721-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-0721-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-0721-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-0721-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-0721-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-0721-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-0721-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-0721-1	`ad56d346431e…`	`cc804d4bbf1e…`

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
N018861-001	BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018861-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018861-001	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB	RLD, RS	1983-08-31	`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	N018861-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018861-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018861-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018861-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018861-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018861-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018861-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018861-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018861-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018861-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018861-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018861-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018861-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018861-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018861-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018861-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018861-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018861-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018861-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018861-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018861-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018861-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018861-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018861-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018861-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018861-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018861-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018861-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018861-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018861-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018861-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018861-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018861-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018861-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018861-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018861-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018861-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018861-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018861-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018861-001	AB	1	`e64feba35796…`

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
Betamethasone Valerate	BETAMETHASONE VALERATE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	0b386ccc-a2d4-4d18-a2d7-e46ff894c674	2026-01-28	Adverse reactions	Exact identifier application applno (NDA): 018861 application number: NDA018861
Betamethasone Valerate	BETAMETHASONE VALERATE	Preferred Pharmaceuticals Inc.	985d1f62-4bff-4bf1-b7c7-96cb456ef83d	2025-02-07	Adverse reactions	Exact identifier application applno (NDA): 018861 application number: NDA018861
Betamethasone Valerate	BETAMETHASONE VALERATE	Proficient Rx LP	036706f1-0a24-4765-9a62-820ad64934be	2022-06-01	Adverse reactions	Exact identifier application applno (NDA): 018861 application number: NDA018861

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9IFA5XM7R2	BETAMETHASONE VALERATE	2152-44-5	BETAMETHASONE VALERATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-0721-0	70518072100	15 g in 1 TUBE (70518-0721-0)	15 g	2017-08-31	0000-00-00	No	No	Current