FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
Unii826Y60901U
Rxcui1738536, 1738541

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68040-714-082026-01-29C16284748780-149896155-c5db-586f-e063-e6dba90add90These 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 topical use Initial U.S. Approval: 1975
68040-714-282026-01-29C16284748780-149896155-c5db-586f-e063-e6dba90add90These 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 topical use Initial U.S. Approval: 1975

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

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, SPRAY2021-06-28NoNoHistorical
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