DESMOPRESSIN ACETATE

Product NDC
43598-931
11-digit product format
435980931
Labeler code
43598
Product ID
43598-931_bf0a845a-fd5e-48e2-f068-1d080d97ff40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESMOPRESSIN ACETATE
Dosage form
INJECTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Dr.Reddys' Laboratories Inc
Application
ANDA210218
Marketing category
ANDA
Marketing start
2020-04-03
Substance
DESMOPRESSIN ACETATE
Active strength
4 ug/mL
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 ACETATE4 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiXB13HYU18U
Rxcui1723232

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
43598-931-09DESMOPRESSIN ACETATE10 in 1 BOXINJECTION101
43598-931-09DESMOPRESSIN ACETATE1 mL in 1 AMPULEINJECTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-931-09ML - Milliliter43598-9310464f9aa-127f-46e6-97fd-b3500051b80b12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-931DESMOPRESSIN ACETATE INJECTION [DR.REDDYS' LABORATORIES INC]1Current NDC, Legacy NDC, 2 package rows20200403_15179e0c-f677-307f-d1e1-5910de4c212f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723232desmopressin acetate 4 MCG in 1 ML InjectionPSN15179e0c-f677-307f-d1e1-5910de4c212f1
17232321 ML desmopressin acetate 0.004 MG/ML InjectionSCD15179e0c-f677-307f-d1e1-5910de4c212f1
1723232desmopressin acetate 4 MCG per 1 ML InjectionSY15179e0c-f677-307f-d1e1-5910de4c212f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-931-094359809310910 AMPULE in 1 BOX (43598-931-09) / 1 mL in 1 AMPULE10 ampule2020-04-030000-00-00NoNoCurrent