FDA.reportPublic FDA data

Desmopressin Acetate

Product NDC
65145-183
Requested package NDC
65145-183-10
11-digit product format
651450183
Labeler code
65145
Product ID
65145-183_84dbb392-4535-4cbc-af60-75abb494f26e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desmopressin Acetate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA219981
Marketing category
ANDA
Marketing start
2026-03-16
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
849501Internal RxNorm lookup
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
84dbb392-4535-4cbc-af60-75abb494f26eAvailable on FDA.report

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
65145-183-01Desmopressin Acetate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION11
65145-183-10Desmopressin Acetate10 in 1 CARTONINJECTION, SOLUTION101

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
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
ndc (package): 65145-183-10
ndc (product): 65145-183
ndc11 (package): 65145018310

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723232desmopressin acetate 4 MCG in 1 ML InjectionPSN84dbb392-4535-4cbc-af60-75abb494f26e1
849501desmopressin acetate 4 MCG/ML Injectable SolutionPSN84dbb392-4535-4cbc-af60-75abb494f26e1
17232321 ML desmopressin acetate 0.004 MG/ML InjectionSCD84dbb392-4535-4cbc-af60-75abb494f26e1
849501desmopressin acetate 0.004 MG/ML Injectable SolutionSCD84dbb392-4535-4cbc-af60-75abb494f26e1
1723232desmopressin acetate 4 MCG per 1 ML InjectionSY84dbb392-4535-4cbc-af60-75abb494f26e1
849501desmopressin acetate 4 MCG/ML Injectable SolutionSY84dbb392-4535-4cbc-af60-75abb494f26e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65145-183-106514501831010 VIAL, SINGLE-DOSE in 1 CARTON (65145-183-10) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-183-01) 2026-03-16NoNoCurrent