Desmopressin Acetate

Product NDC
10702-169
11-digit product format
107020169
Labeler code
10702
Product ID
10702-169_11e764a6-0d02-ec11-e063-6394a90a195e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desmopressin Acetate
Dosage form
TABLET
Route
ORAL
Labeler
KVK-TECH, INC.
Application
ANDA210371
Marketing category
ANDA
Marketing start
2019-01-28
Substance
DESMOPRESSIN ACETATE
Active strength
.1 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

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
A210371-001DESMOPRESSIN ACETATEDESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-28
A210371-002DESMOPRESSIN ACETATEDESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210371-001AB
A210371-002AB

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 06:07:402026-07A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210371-001DESMOPRESSIN ACETATE0.1MGTABLET / ORALAB2019-01-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210371-002DESMOPRESSIN ACETATE0.2MGTABLET / ORALAB2019-01-28bb7c543d1eb4…

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 06:07:402026-07A210371-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210371-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210371-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210371-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210371-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210371-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210371-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210371-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210371-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210371-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210371-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210371-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210371-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210371-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210371-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210371-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210371-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210371-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210371-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210371-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210371-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210371-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210371-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210371-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210371-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210371-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210371-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210371-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210371-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210371-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210371-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210371-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210371-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210371-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210371-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210371-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210371-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210371-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210371-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210371-002AB1bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESMOPRESSIN ACETATE.1 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
9fba5e90-f541-4588-a5e9-b56198f17e87Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10702-169-012024-02-21C16284748780-11030e365-0f53-111a-e063-dadaa90a10e2Desmopressin Acetate Tablets
10702-169-012024-01-30C16284748780-11030e365-0f53-111a-e063-dadaa90a10e2Desmopressin Acetate Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-169-01Desmopressin Acetate100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-169-01EA - Each10702-1691a0607e4-570c-4e48-bf7b-94a56567bcbf12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-169DESMOPRESSIN ACETATE TABLET [KVK-TECH, INC.]4Current NDC, Legacy NDC, 1 package rows20240223_9fba5e90-f541-4588-a5e9-b56198f17e87.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Desmopressin AcetateDESMOPRESSIN ACETATENorthwind Health Company, LLCf306e2d4-781f-ff8f-e053-2a95a90ad15b2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210371
application number: ANDA210371
Desmopressin AcetateDESMOPRESSIN ACETATEKVK-TECH, INC.9fba5e90-f541-4588-a5e9-b56198f17e872024-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210371
application number: ANDA210371
ndc (product): 10702-169

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849515desmopressin acetate 0.1 MG Oral TabletPSN9fba5e90-f541-4588-a5e9-b56198f17e874
833008desmopressin acetate 0.2 MG Oral TabletPSN9fba5e90-f541-4588-a5e9-b56198f17e874
849515desmopressin acetate 0.1 MG Oral TabletSCD9fba5e90-f541-4588-a5e9-b56198f17e874
833008desmopressin acetate 0.2 MG Oral TabletSCD9fba5e90-f541-4588-a5e9-b56198f17e874

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-169-0110702016901100 TABLET in 1 BOTTLE (10702-169-01) 100 tablet2019-01-280000-00-00NoNoCurrent