FDA.reportPublic FDA data

Desmopressin Acetate

Product NDC
72485-523
11-digit product format
724850523
Labeler code
72485
Product ID
72485-523_ff825351-c532-421f-9aad-569ca5efbd59
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desmopressin Acetate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS; SUBCUTANEOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA219981
Marketing category
ANDA
Marketing start
2026-06-30
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A219981-001DESMOPRESSIN ACETATEDESMOPRESSIN ACETATE0.004MG/MLINJECTABLE / INJECTIONAP2026-02-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A219981-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A219981-001DESMOPRESSIN ACETATE0.004MG/MLINJECTABLE / INJECTIONAP2026-02-2784e616aacf4f…
2026-08-18 06:07:402026-07A219981-001DESMOPRESSIN ACETATE0.004MG/MLINJECTABLE / INJECTIONAP2026-02-27caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219981-001DESMOPRESSIN ACETATE0.004MG/MLINJECTABLE / INJECTIONAP2026-02-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219981-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A219981-001AP1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219981-001AP1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESMOPRESSIN ACETATE4 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
XB13HYU18UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1723232Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d87168b9-f103-4ba5-b0b3-0656d1c81da2Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Desmopressin AcetateDESMOPRESSIN ACETATEArmas Pharmaceuticals Inc.d87168b9-f103-4ba5-b0b3-0656d1c81da22026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219981
application number: ANDA219981
ndc (product): 72485-523
Desmopressin AcetateDESMOPRESSIN ACETATEArmas Pharmaceuticals Inc.673cd9ab-b714-49ee-9ce7-c99be605c30e2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219981
application number: ANDA219981
Desmopressin AcetateDESMOPRESSIN ACETATECaplin Steriles Limited84dbb392-4535-4cbc-af60-75abb494f26e2026-03-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219981
application number: ANDA219981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72485-523-107248505231010 VIAL, SINGLE-DOSE in 1 CARTON (72485-523-10) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-523-01) 2026-06-30NoNoCurrent