Home NDC 68040-714 Sernivo
Product NDC 68040-714
11-digit product format 680400714
Labeler code 68040
Product ID 68040-714_8310ee9a-2de4-4246-a1ed-6fd23d041962
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name betamethasone dipropionate
Dosage form SPRAY
Route TOPICAL
Labeler Primus Pharmaceuticals, Inc.
Application NDA208079
Marketing category NDA
Marketing start 2021-06-28
Substance BETAMETHASONE DIPROPIONATE
Active strength .5 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 Product TE source text 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…
Additional Listing Data#
Finished product Yes
Brand name base Sernivo
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BETAMETHASONE DIPROPIONATE .5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 826Y60901U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1738536 Internal RxNorm lookup 1738541 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68040-714-08 Sernivo 1 in 1 Carton Spray 1 7 68040-714-08 Sernivo 10 g in 1 Bottle, Spray Spray 10 7 68040-714-28 Sernivo 1 in 1 Carton Spray 1 7 68040-714-28 Sernivo 120 g in 1 Bottle, Spray Spray 120 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68040-714 SERNIVO (BETAMETHASONE DIPROPIONATE) SPRAY [PRIMUS PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 4 package rows 20240131_b1b3d1b0-da9b-11eb-ad76-0800200c9a66.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 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 ndc (product): 68040-714
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68040-714-08 68040071408 1 BOTTLE, SPRAY in 1 CARTON (68040-714-08) / 10 g in 1 BOTTLE, SPRAY 2021-06-28 No No Current 68040-714-28 68040071428 1 BOTTLE, SPRAY in 1 CARTON (68040-714-28) / 120 g in 1 BOTTLE, SPRAY 2021-06-28 2028-04-30 No No Current 68040-714-99 68040071499 1 BOTTLE, SPRAY in 1 CARTON (68040-714-99) > 120 g in 1 BOTTLE, SPRAY 2021-06-28 0000-00-00 No No Current