Desmopressin Acetate

Product NDC
69918-101
11-digit product format
699180101
Labeler code
69918
Product ID
69918-101_8f843a4f-10ba-4f8c-a86e-f599dbb7f322
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desmopressin Acetate
Dosage form
TABLET
Route
ORAL
Labeler
Nordic Pharma, Inc.
Application
NDA019955
Marketing category
NDA
Marketing start
2015-12-10
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
N019955-001DDAVPDESMOPRESSIN ACETATE0.1MGTABLET / ORALABRLD1995-09-06
N019955-002DDAVPDESMOPRESSIN ACETATE0.2MGTABLET / ORALABRLD, RS1995-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019955-001AB
N019955-002AB

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 06:07:402026-07N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-06caaa826d4ba7…
2026-08-18 06:07:402026-07N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-06d06236e962d9…
2024-10-29 15:01 UTC2024-10N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019955-001DDAVP0.1MGTABLET / ORALABRLD1995-09-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019955-002DDAVP0.2MGTABLET / ORALABRLD, RS1995-09-06bb7c543d1eb4…

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 06:07:402026-07N019955-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N019955-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019955-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019955-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019955-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019955-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019955-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019955-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019955-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019955-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019955-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019955-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019955-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019955-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019955-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019955-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019955-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019955-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019955-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019955-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019955-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N019955-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019955-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019955-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019955-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019955-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019955-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019955-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019955-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N019955-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019955-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019955-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019955-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N019955-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019955-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N019955-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019955-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N019955-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019955-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N019955-002AB1bb7c543d1eb4…

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
c01048e8-d28f-4085-9c37-3d5d48395a77Available 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
69918-101-01Desmopressin Acetate100 in 1 BOTTLETABLET1008
69918-101-01Desmopressin Acetate1 in 1 CARTONTABLET18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69918-101-01EA - Each69918-10131941b4b-0148-423c-9d8c-e6df10b0c15712016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Desmopressin AcetateACTIVE INGREDIENTXB13HYU18UDESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]1
desmopressinACTIVE MOIETYENR1LLB0FPDESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]1
LactoseINACTIVE INGREDIENTJ2B2A4N98GDESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30DESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]1
PovidonesINACTIVE INGREDIENTFZ989GH94EDESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]1
Starch, PotatoINACTIVE INGREDIENT8I089SAH3TDESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69918-101DESMOPRESSIN ACETATE TABLET [NORDIC PHARMA, INC.]8Current NDC, Legacy NDC, 2 package rows20241210_c01048e8-d28f-4085-9c37-3d5d48395a77.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Desmopressin AcetateDESMOPRESSIN ACETATEBryant Ranch Prepack52133714-37d1-458d-9839-f0bd206711ea2025-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 019955
application number: NDA019955
Desmopressin AcetateDESMOPRESSIN ACETATENordic Pharma, Inc.c01048e8-d28f-4085-9c37-3d5d48395a772024-12-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 019955
application number: NDA019955
ndc (product): 69918-101
DDAVPDESMOPRESSIN ACETATEFerring Pharmaceuticals Inc.6d55baa9-2b62-469c-93ae-3909ab2493322021-02-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 019955
application number: NDA019955

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849515desmopressin acetate 0.1 MG Oral TabletPSNc01048e8-d28f-4085-9c37-3d5d48395a778
833008desmopressin acetate 0.2 MG Oral TabletPSNc01048e8-d28f-4085-9c37-3d5d48395a778
849515desmopressin acetate 0.1 MG Oral TabletSCDc01048e8-d28f-4085-9c37-3d5d48395a778
833008desmopressin acetate 0.2 MG Oral TabletSCDc01048e8-d28f-4085-9c37-3d5d48395a778

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69918-101-01699180101011 BOTTLE in 1 CARTON (69918-101-01) / 100 TABLET in 1 BOTTLE1 bottle2015-12-100000-00-00NoNoCurrent