Sernivo

Product NDC: 67857-808
11-digit product format: 678570808
Labeler code: 67857
Product ID: 67857-808_87e07b91-6b99-09b8-9d58-240ec3ad06de
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: betamethasone dipropionate
Dosage form: SPRAY
Route: TOPICAL
Labeler: Promius Pharma, LLC
Application: NDA208079
Marketing category: NDA
Marketing start: 2016-02-22
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67857-808		D	Discontinued by firm		2026-08-07
excluded package	package	67857-808	67857-808-04	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	67857-808-04	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	67857-808-04	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	67857-808-04	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	67857-808-04	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	67857-808-04	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	67857-808-04	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	67857-808-04	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	67857-808-04	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	67857-808-04	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	67857-808-04	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	67857-808-04	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	67857-808-04	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	67857-808-04	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	67857-808-04	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	67857-808-04	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
N208079-001	SERNIVO	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL		RLD, RS	2016-02-05

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208079-001	10179137	2030-08-31	U-1858	Drug product	2019-02-08
N208079-001	9364485	2030-08-31	U-1858	Drug product	2016-06-29
N208079-001	9433630	2030-08-31	U-1858	Drug product	2016-09-14
N208079-001	9439911	2030-08-31	U-1858	Drug product	2016-09-21
N208079-001	9655907	2030-08-31	U-1858	Drug product	2017-06-02
N208079-001	9775851	2030-08-31	U-1858	Drug product	2017-10-17
N208079-001	9877974	2030-08-31	U-1858	Drug product	2018-02-15

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	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208079-001	SERNIVO	EQ 0.05% BASE/SPRAY	SPRAY / TOPICAL	RLD, RS	2016-02-05	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 287 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	N208079-001	10179137	2030-08-31	U-1858	Drug product	2019-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208079-001	9364485	2030-08-31	U-1858	Drug product	2016-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208079-001	9433630	2030-08-31	U-1858	Drug product	2016-09-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208079-001	9439911	2030-08-31	U-1858	Drug product	2016-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208079-001	9655907	2030-08-31	U-1858	Drug product	2017-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208079-001	9775851	2030-08-31	U-1858	Drug product	2017-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208079-001	9877974	2030-08-31	U-1858	Drug product	2018-02-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208079-001	10179137	2030-08-31	U-1858	Drug product	2019-02-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208079-001	9364485	2030-08-31	U-1858	Drug product	2016-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208079-001	9433630	2030-08-31	U-1858	Drug product	2016-09-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208079-001	9439911	2030-08-31	U-1858	Drug product	2016-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208079-001	9655907	2030-08-31	U-1858	Drug product	2017-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208079-001	9775851	2030-08-31	U-1858	Drug product	2017-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208079-001	9877974	2030-08-31	U-1858	Drug product	2018-02-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208079-001	10179137	2030-08-31	U-1858	Drug product	2019-02-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208079-001	9364485	2030-08-31	U-1858	Drug product	2016-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208079-001	9433630	2030-08-31	U-1858	Drug product	2016-09-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208079-001	9439911	2030-08-31	U-1858	Drug product	2016-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208079-001	9655907	2030-08-31	U-1858	Drug product	2017-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208079-001	9775851	2030-08-31	U-1858	Drug product	2017-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208079-001	9877974	2030-08-31	U-1858	Drug product	2018-02-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208079-001	10179137	2030-08-31	U-1858	Drug product	2019-02-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208079-001	9364485	2030-08-31	U-1858	Drug product	2016-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208079-001	9433630	2030-08-31	U-1858	Drug product	2016-09-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208079-001	9439911	2030-08-31	U-1858	Drug product	2016-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208079-001	9655907	2030-08-31	U-1858	Drug product	2017-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208079-001	9775851	2030-08-31	U-1858	Drug product	2017-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208079-001	9877974	2030-08-31	U-1858	Drug product	2018-02-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208079-001	10179137	2030-08-31	U-1858	Drug product	2019-02-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208079-001	9364485	2030-08-31	U-1858	Drug product	2016-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208079-001	9433630	2030-08-31	U-1858	Drug product	2016-09-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208079-001	9439911	2030-08-31	U-1858	Drug product	2016-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208079-001	9655907	2030-08-31	U-1858	Drug product	2017-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208079-001	9775851	2030-08-31	U-1858	Drug product	2017-10-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208079-001	9877974	2030-08-31	U-1858	Drug product	2018-02-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208079-001	10179137	2030-08-31	U-1858	Drug product	2019-02-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208079-001	9364485	2030-08-31	U-1858	Drug product	2016-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208079-001	9433630	2030-08-31	U-1858	Drug product	2016-09-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208079-001	9439911	2030-08-31	U-1858	Drug product	2016-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208079-001	9655907	2030-08-31	U-1858	Drug product	2017-06-02	`03ed91905a0d…`

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	N208079-001	NDF	2019-02-05	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N208079-001	NDF	2019-02-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208079-001	NDF	2019-02-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208079-001	NDF	2019-02-05	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67857-808-04	2025-02-14	C162847	48780-1	f386c649-e20c-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use SERNIVO ® Spray safely and effectively. See full prescribing information for SERNIVO ® Spray. SERNIVO ® (betamethasone dipropionate) Spray, for 0.05% for topical use Initial U.S. Approval: 1975
67857-808-04	2023-01-30	C162847	48780-1	f386c649-e20c-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use SERNIVO ® Spray safely and effectively. See full prescribing information for SERNIVO ® Spray. SERNIVO ® (betamethasone dipropionate) Spray, for 0.05% for topical use Initial U.S. Approval: 1975

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67857-808-04	ML - Milliliter	67857-808	4bd2ec50-1109-4fbb-8db9-44c5f8eafcf4	1	2016-04-04

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
Sernivo	BETAMETHASONE DIPROPIONATE	Primus Pharmaceuticals, Inc.	b1b3d1b0-da9b-11eb-ad76-0800200c9a66	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208079 application number: NDA208079

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67857-808-04	67857080804	1 BOTTLE in 1 CARTON (67857-808-04) > 120 g in 1 BOTTLE	1 bottle	2016-02-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sernivo	Promius Pharma, LLC \| Crystal Pharma S.A.U. \| DPT Laboratories, Ltd. \| Sharp Corporation	2018-11-30	HUMAN PRESCRIPTION DRUG LABEL	3