Desmopressin Acetate

Product NDC
69918-901
11-digit product format
699180901
Labeler code
69918
Product ID
69918-901_13ec577b-9bd8-4429-ad53-f8bf5a118995
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desmopressin Acetate
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Nordic Pharma, Inc.
Application
NDA018938
Marketing category
NDA
Marketing start
2016-01-20
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
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
N018938-001DDAVPDESMOPRESSIN ACETATE0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-30
N018938-002DDAVPDESMOPRESSIN ACETATE0.015MG/MLINJECTABLE / INJECTION1995-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018938-001AP

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.

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 06:07:402026-07N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018938-001DDAVP0.004MG/MLINJECTABLE / INJECTIONAPRLD, RS1984-03-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N018938-002DDAVP0.015MG/MLINJECTABLE / INJECTION1995-04-25bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018938-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018938-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018938-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018938-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018938-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018938-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018938-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018938-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018938-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018938-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018938-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018938-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018938-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018938-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018938-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018938-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018938-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018938-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018938-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018938-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018938-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018938-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N018938-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018938-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018938-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018938-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N018938-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018938-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018938-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018938-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018938-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018938-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018938-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018938-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018938-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018938-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018938-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018938-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018938-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018938-001AP1e64feba35796…

Additional Listing Data#

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

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
29df0492-f7ef-47bb-aa67-4ef9e5c2846fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bde14c5d-9a3e-43bd-a8e6-0fb00287bdacProduct name620250127
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
64db728f-18f9-4c58-ba09-60fd6f75f709Product name220190613
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
aa3ade84-795a-4f84-bfdf-ebe397f656f5Product name120190402
d8c9f9fc-e302-45b4-9b21-a802f2592402Product name120180810
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
4bbcef53-5c79-462a-b7ba-cff48fe1fb5aProduct name120171129
74cda04a-3bd1-4535-800b-d9b9265e3211Product name220171129
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
50d55b09-49b8-f134-6bdc-eb6402b911dcProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69918-901-10Desmopressin Acetate1 in 1 CARTONSOLUTION113
69918-901-10Desmopressin Acetate10 mL in 1 VIAL, MULTI-DOSESOLUTION1013
69918-901-11Desmopressin Acetate10 mL in 1 VIAL, MULTI-DOSESOLUTION107
69918-901-11Desmopressin Acetate1 in 1 CARTONSOLUTION17
69918-901-12Desmopressin Acetate10 mL in 1 VIAL, MULTI-DOSESOLUTION106
69918-901-12Desmopressin Acetate1 in 1 CARTONSOLUTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69918-901-10ML - Milliliter69918-9010d8f5a57-5ad0-4173-aefc-742ddf0f19ed12016-02-04
69918-901-11ML - Milliliter69918-90100c3d211-11e8-4ca0-9c2d-d1826e99d81a12022-02-07
69918-901-12ML - Milliliter69918-90117bdeb27-958b-41c5-80cd-3a0155a8883e12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Desmopressin AcetateACTIVE INGREDIENTXB13HYU18UDESMOPRESSIN ACETATE SOLUTION [AMRING PHARMACEUTICALS INC.]1
desmopressinACTIVE MOIETYENR1LLB0FPDESMOPRESSIN ACETATE SOLUTION [AMRING PHARMACEUTICALS INC.]1
ChlorobutanolINACTIVE INGREDIENTHM4YQM8WRCDESMOPRESSIN ACETATE SOLUTION [AMRING PHARMACEUTICALS INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBDESMOPRESSIN ACETATE SOLUTION [AMRING PHARMACEUTICALS INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XDESMOPRESSIN ACETATE SOLUTION [AMRING PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69918-901DESMOPRESSIN ACETATE SOLUTION [NORDIC PHARMA, INC.]11Current NDC, Legacy NDC, 2 package rows20250130_29df0492-f7ef-47bb-aa67-4ef9e5c2846f.zip
69918-901DESMOPRESSIN ACETATE SOLUTION [NORDIC PHARMA, INC.]5Current NDC, Legacy NDC, 2 package rows20241211_10b29aa2-274e-4c29-bccd-424bd3761758.zip
69918-901DESMOPRESSIN ACETATE SOLUTION [NORDIC PHARMA, INC.]5Current NDC, Legacy NDC, 2 package rows20241210_131fd4d8-48ca-4c1f-8165-848dc0a4d511.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 ACETATENordic Pharma, Inc.29df0492-f7ef-47bb-aa67-4ef9e5c2846f2025-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018938
application number: NDA018938
ndc (product): 69918-901
Desmopressin AcetateDESMOPRESSIN ACETATENordic Pharma, Inc.10b29aa2-274e-4c29-bccd-424bd37617582025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018938
application number: NDA018938
ndc (product): 69918-901
Desmopressin AcetateDESMOPRESSIN ACETATENordic Pharma, Inc.131fd4d8-48ca-4c1f-8165-848dc0a4d5112025-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018938
application number: NDA018938
ndc (product): 69918-901
DDAVPDESMOPRESSIN ACETATEFerring Pharmaceuticals Inc.651f6fee-a2c7-431b-8d5d-58b156c722442022-09-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018938
application number: NDA018938

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723232desmopressin acetate 4 MCG in 1 ML InjectionPSN29df0492-f7ef-47bb-aa67-4ef9e5c2846f13
849501desmopressin acetate 4 MCG/ML Injectable SolutionPSN29df0492-f7ef-47bb-aa67-4ef9e5c2846f13
17232321 ML desmopressin acetate 0.004 MG/ML InjectionSCD29df0492-f7ef-47bb-aa67-4ef9e5c2846f13
849501desmopressin acetate 0.004 MG/ML Injectable SolutionSCD29df0492-f7ef-47bb-aa67-4ef9e5c2846f13
1723232desmopressin acetate 4 MCG per 1 ML InjectionSY29df0492-f7ef-47bb-aa67-4ef9e5c2846f13
849501desmopressin acetate 4 MCG/ML Injectable SolutionSY29df0492-f7ef-47bb-aa67-4ef9e5c2846f13
1723232desmopressin acetate 4 MCG in 1 ML InjectionPSN10b29aa2-274e-4c29-bccd-424bd37617587
849501desmopressin acetate 4 MCG/ML Injectable SolutionPSN10b29aa2-274e-4c29-bccd-424bd37617587
17232321 ML desmopressin acetate 0.004 MG/ML InjectionSCD10b29aa2-274e-4c29-bccd-424bd37617587
849501desmopressin acetate 0.004 MG/ML Injectable SolutionSCD10b29aa2-274e-4c29-bccd-424bd37617587
1723232desmopressin acetate 4 MCG per 1 ML InjectionSY10b29aa2-274e-4c29-bccd-424bd37617587
849501desmopressin acetate 4 MCG/ML Injectable SolutionSY10b29aa2-274e-4c29-bccd-424bd37617587
849501desmopressin acetate 4 MCG/ML Injectable SolutionPSN131fd4d8-48ca-4c1f-8165-848dc0a4d5116
849501desmopressin acetate 0.004 MG/ML Injectable SolutionSCD131fd4d8-48ca-4c1f-8165-848dc0a4d5116
849501desmopressin acetate 4 MCG/ML Injectable SolutionSY131fd4d8-48ca-4c1f-8165-848dc0a4d5116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69918-901-10699180901101 VIAL, MULTI-DOSE in 1 CARTON (69918-901-10) / 10 mL in 1 VIAL, MULTI-DOSE2016-01-200000-00-00NoNoCurrent
69918-901-11699180901111 VIAL, MULTI-DOSE in 1 CARTON (69918-901-11) / 10 mL in 1 VIAL, MULTI-DOSE2022-01-070000-00-00NoNoCurrent
69918-901-12699180901121 VIAL, MULTI-DOSE in 1 CARTON (69918-901-12) / 10 mL in 1 VIAL, MULTI-DOSE2022-05-090000-00-00NoNoCurrent