Desmopressin Acetate

Product NDC
60505-0258
11-digit product format
605050258
Labeler code
60505
Product ID
60505-0258_41d13d8f-eeae-838d-fd10-bf7f568e903b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desmopressin acetate
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA077414
Marketing category
ANDA
Marketing start
2006-03-07
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60505-025860505-0258-3DDiscontinued by firm2026-08-17
excluded packagepackage60505-025860505-0258-8DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0560505-0258-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0560505-0258-8d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2660505-0258-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2660505-0258-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3160505-0258-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3160505-0258-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2860505-0258-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2860505-0258-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2160505-0258-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2160505-0258-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1060505-0258-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1060505-0258-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3160505-0258-8302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3160505-0258-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2060505-0258-8ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2060505-0258-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1060505-0258-80efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1060505-0258-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0860505-0258-8ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0860505-0258-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0360505-0258-8367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0360505-0258-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0960505-0258-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0960505-0258-8557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077414-001DESMOPRESSIN ACETATEDESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-07
A077414-002DESMOPRESSIN ACETATEDESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077414-001AB
A077414-002AB

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-07caaa826d4ba7…
2026-08-18 06:07:402026-07A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077414-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2006-03-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077414-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2006-03-07bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077414-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077414-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077414-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077414-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077414-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077414-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077414-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077414-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077414-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077414-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077414-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077414-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077414-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077414-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077414-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077414-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077414-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077414-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077414-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077414-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077414-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077414-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077414-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077414-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077414-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077414-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077414-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077414-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077414-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077414-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077414-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077414-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077414-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077414-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077414-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077414-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077414-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077414-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077414-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077414-002AB1bb7c543d1eb4…

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 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
833008Internal RxNorm lookup
849515Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
72aeef35-c102-b628-0219-9822651887ebAvailable 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
60505-0258-1Desmopressin Acetate100 in 1 BOTTLETABLET1009
60505-0258-3Desmopressin Acetate30 in 1 BOTTLETABLET309
60505-0258-8Desmopressin Acetate1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0258-1EA - Each60505-0258a292e59e-c3fa-4ca5-b0e5-07cbb50d33bc12013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DESMOPRESSIN ACETATEACTIVE INGREDIENTXB13HYU18UDESMOPRESSIN ACETATE TABLET [APOTEX CORP.]3
DesmopressinACTIVE MOIETYENR1LLB0FPDESMOPRESSIN ACETATE TABLET [APOTEX CORP.]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDESMOPRESSIN ACETATE TABLET [APOTEX CORP.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DESMOPRESSIN ACETATE TABLET [APOTEX CORP.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDESMOPRESSIN ACETATE TABLET [APOTEX CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0258DESMOPRESSIN ACETATE TABLET [APOTEX CORP.]8Current NDC, Legacy NDC, 3 package rows20240926_72aeef35-c102-b628-0219-9822651887eb.zip

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Desmopressin AcetateDESMOPRESSIN ACETATEAmerican Health Packaging0d447b48-3f4b-430e-9e68-d8b9401c002e2025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077414
application number: ANDA077414
Desmopressin AcetateDESMOPRESSIN ACETATEBryant Ranch Prepackdc9b0dad-d265-4dff-8191-d936280d85a22025-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077414
application number: ANDA077414
Desmopressin AcetateDESMOPRESSIN ACETATEApotex Corp.72aeef35-c102-b628-0219-9822651887eb2025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077414
application number: ANDA077414
ndc (product): 60505-0258
Desmopressin AcetateDESMOPRESSIN ACETATEBluePoint Laboratoriesc04357fd-478a-4909-b098-ae6710be071c2023-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077414
application number: ANDA077414

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833008desmopressin acetate 0.2 MG Oral TabletPSNdc9b0dad-d265-4dff-8191-d936280d85a2102
833008desmopressin acetate 0.2 MG Oral TabletSCDdc9b0dad-d265-4dff-8191-d936280d85a2102
849515desmopressin acetate 0.1 MG Oral TabletPSN72aeef35-c102-b628-0219-9822651887eb9
833008desmopressin acetate 0.2 MG Oral TabletPSN72aeef35-c102-b628-0219-9822651887eb9
849515desmopressin acetate 0.1 MG Oral TabletSCD72aeef35-c102-b628-0219-9822651887eb9
833008desmopressin acetate 0.2 MG Oral TabletSCD72aeef35-c102-b628-0219-9822651887eb9
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 startMarketing endSampleExclude flagStatus
60505-0258-160505025801100 TABLET in 1 BOTTLE (60505-0258-1) 100 tablet2006-03-070000-00-00NoNoCurrent
60505-0258-36050502580330 TABLET in 1 BOTTLE (60505-0258-3) 30 tablet2006-03-070000-00-00NoNoCurrent
60505-0258-8605050258081000 TABLET in 1 BOTTLE (60505-0258-8) 1000 tablet2006-03-070000-00-00NoNoCurrent