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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208079-001SERNIVOBETAMETHASONE DIPROPIONATEEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208079-001101791372030-08-31U-1858Drug product2019-02-08
N208079-00193644852030-08-31U-1858Drug product2016-06-29
N208079-00194336302030-08-31U-1858Drug product2016-09-14
N208079-00194399112030-08-31U-1858Drug product2016-09-21
N208079-00196559072030-08-31U-1858Drug product2017-06-02
N208079-00197758512030-08-31U-1858Drug product2017-10-17
N208079-00198779742030-08-31U-1858Drug product2018-02-15

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-0587673890dc5c…
2021-03-12 10:30 UTC2021-03N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-053f01610625f2…
2019-09-15 20:21 UTC2019-09N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05b00525d2431f…
2019-07-19 19:46 UTC2019-07N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-053f0d92c62455…
2023-05-13 08:27 UTC2023-05N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05053a50430f4f…
2023-01-26 05:58 UTC2023-01N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208079-001SERNIVOEQ 0.05% BASE/SPRAYSPRAY / TOPICALRLD, RS2016-02-05cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208079-001101791372030-08-31U-1858Drug product2019-02-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208079-00193644852030-08-31U-1858Drug product2016-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208079-00194336302030-08-31U-1858Drug product2016-09-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208079-00194399112030-08-31U-1858Drug product2016-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208079-00196559072030-08-31U-1858Drug product2017-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208079-00197758512030-08-31U-1858Drug product2017-10-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208079-00198779742030-08-31U-1858Drug product2018-02-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208079-001101791372030-08-31U-1858Drug product2019-02-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208079-00193644852030-08-31U-1858Drug product2016-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208079-00194336302030-08-31U-1858Drug product2016-09-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208079-00194399112030-08-31U-1858Drug product2016-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208079-00196559072030-08-31U-1858Drug product2017-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208079-00197758512030-08-31U-1858Drug product2017-10-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208079-00198779742030-08-31U-1858Drug product2018-02-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N208079-001101791372030-08-31U-1858Drug product2019-02-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208079-00193644852030-08-31U-1858Drug product2016-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208079-00194336302030-08-31U-1858Drug product2016-09-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208079-00194399112030-08-31U-1858Drug product2016-09-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208079-00196559072030-08-31U-1858Drug product2017-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208079-00197758512030-08-31U-1858Drug product2017-10-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208079-00198779742030-08-31U-1858Drug product2018-02-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208079-001101791372030-08-31U-1858Drug product2019-02-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208079-00193644852030-08-31U-1858Drug product2016-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208079-00194336302030-08-31U-1858Drug product2016-09-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208079-00194399112030-08-31U-1858Drug product2016-09-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208079-00196559072030-08-31U-1858Drug product2017-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208079-00197758512030-08-31U-1858Drug product2017-10-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208079-00198779742030-08-31U-1858Drug product2018-02-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208079-001101791372030-08-31U-1858Drug product2019-02-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208079-00193644852030-08-31U-1858Drug product2016-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208079-00194336302030-08-31U-1858Drug product2016-09-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208079-00194399112030-08-31U-1858Drug product2016-09-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208079-00196559072030-08-31U-1858Drug product2017-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208079-00197758512030-08-31U-1858Drug product2017-10-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208079-00198779742030-08-31U-1858Drug product2018-02-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208079-001101791372030-08-31U-1858Drug product2019-02-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208079-00193644852030-08-31U-1858Drug product2016-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208079-00194336302030-08-31U-1858Drug product2016-09-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208079-00194399112030-08-31U-1858Drug product2016-09-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208079-00196559072030-08-31U-1858Drug product2017-06-0203ed91905a0d…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N208079-001NDF2019-02-0574a2ff9319b5…
2019-12-14 00:12 UTC2019-12N208079-001NDF2019-02-053f01610625f2…
2019-09-15 20:21 UTC2019-09N208079-001NDF2019-02-05b00525d2431f…
2019-07-19 19:46 UTC2019-07N208079-001NDF2019-02-05ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Sernivo
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE DIPROPIONATE.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
826Y60901UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1738536Internal RxNorm lookup
1738541Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b1b3d1b0-da9b-11eb-ad76-0800200c9a66Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68040-714-08Sernivo1 in 1 CartonSpray17
68040-714-08Sernivo10 g in 1 Bottle, SpraySpray107
68040-714-28Sernivo1 in 1 CartonSpray17
68040-714-28Sernivo120 g in 1 Bottle, SpraySpray1207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68040-714-28ML - Milliliter68040-714abaf2ce7-c405-4105-bcf3-bb7b59ef11ec12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68040-714SERNIVO (BETAMETHASONE DIPROPIONATE) SPRAY [PRIMUS PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 4 package rows20240131_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SernivoBETAMETHASONE DIPROPIONATEPrimus Pharmaceuticals, Inc.b1b3d1b0-da9b-11eb-ad76-0800200c9a662026-04-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 208079
application number: NDA208079
ndc (product): 68040-714

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738536betamethasone 0.05 % Topical SprayPSNb1b3d1b0-da9b-11eb-ad76-0800200c9a667
1738541Sernivo 0.05 % Topical SprayPSNb1b3d1b0-da9b-11eb-ad76-0800200c9a667
1738541betamethasone 0.5 MG/ML Topical Spray [Sernivo]SBDb1b3d1b0-da9b-11eb-ad76-0800200c9a667
1738536betamethasone 0.5 MG/ML Topical SpraySCDb1b3d1b0-da9b-11eb-ad76-0800200c9a667
1738536betamethasone (as dipropionate) 0.05 % Topical SpraySYb1b3d1b0-da9b-11eb-ad76-0800200c9a667
1738536betamethasone dipropionate 0.064 % Topical SpraySYb1b3d1b0-da9b-11eb-ad76-0800200c9a667
1738541Sernivo 0.05 % Topical SpraySYb1b3d1b0-da9b-11eb-ad76-0800200c9a667
1738541Sernivo 0.5 MG/ML Topical SpraySYb1b3d1b0-da9b-11eb-ad76-0800200c9a667

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68040-714-08680400714081 BOTTLE, SPRAY in 1 CARTON (68040-714-08) / 10 g in 1 BOTTLE, SPRAY2021-06-28NoNoCurrent
68040-714-28680400714281 BOTTLE, SPRAY in 1 CARTON (68040-714-28) / 120 g in 1 BOTTLE, SPRAY2021-06-282028-04-30NoNoCurrent
68040-714-99680400714991 BOTTLE, SPRAY in 1 CARTON (68040-714-99) > 120 g in 1 BOTTLE, SPRAY2021-06-280000-00-00NoNoCurrent