FDA.reportPublic FDA data

Desmopressin Acetate

Product NDC
60687-732
11-digit product format
606870732
Labeler code
60687
Product ID
60687-732_437dc780-8fd1-6205-e063-6394a90a19db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desmopressin acetate
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077414
Marketing category
ANDA
Marketing start
2023-12-28
Substance
DESMOPRESSIN ACETATE
Active strength
.2 mg/1
Pharmacologic classes
Factor VIII Activator [EPC], Increased Coagulation Factor VIII Activity [PE], Increased Coagulation Factor VIII Concentration [PE], Vasopressin Analog [EPC], Vasopressins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Desmopressin Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESMOPRESSIN ACETATE.2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXB13HYU18U
Rxcui833008, 849515

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bde14c5d-9a3e-43bd-a8e6-0fb00287bdacProduct name620250127
64db728f-18f9-4c58-ba09-60fd6f75f709Product name220190613
aa3ade84-795a-4f84-bfdf-ebe397f656f5Product name120190402
d8c9f9fc-e302-45b4-9b21-a802f2592402Product name120180810
4bbcef53-5c79-462a-b7ba-cff48fe1fb5aProduct name120171129
74cda04a-3bd1-4535-800b-d9b9265e3211Product name220171129
50d55b09-49b8-f134-6bdc-eb6402b911dcProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-732-11Desmopressin Acetate1 in 1 BLISTER PACKTABLET15
60687-732-21Desmopressin Acetate30 in 1 CARTONTABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-732-11EA - Each60687-73278eeeeb3-4753-4f74-b0be-b3f861b0ab4b12024-01-04
60687-732-21EA - Each60687-732084aaf19-8e7e-4867-846e-3811fa27604a12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-732DESMOPRESSIN ACETATE TABLET [AMERICAN HEALTH PACKAGING]4Current NDC, 2 package rows20240224_0d447b48-3f4b-430e-9e68-d8b9401c002e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849515desmopressin acetate 0.1 MG Oral TabletPSN0d447b48-3f4b-430e-9e68-d8b9401c002e5
833008desmopressin acetate 0.2 MG Oral TabletPSN0d447b48-3f4b-430e-9e68-d8b9401c002e5
849515desmopressin acetate 0.1 MG Oral TabletSCD0d447b48-3f4b-430e-9e68-d8b9401c002e5
833008desmopressin acetate 0.2 MG Oral TabletSCD0d447b48-3f4b-430e-9e68-d8b9401c002e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-732-11606870732111 in 1 BLISTER PACKHistorical
60687-732-216068707322130 BLISTER PACK in 1 CARTON (60687-732-21) / 1 TABLET in 1 BLISTER PACK (60687-732-11) 30 blister pack2023-12-28NoNoHistorical