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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019955-001	DDAVP	DESMOPRESSIN ACETATE	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06
N019955-002	DDAVP	DESMOPRESSIN ACETATE	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06

Therapeutic equivalence codes#

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

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

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 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019955-001	DDAVP	0.1MG	TABLET / ORAL	AB	RLD	1995-09-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019955-002	DDAVP	0.2MG	TABLET / ORAL	AB	RLD, RS	1995-09-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N019955-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019955-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019955-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019955-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019955-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019955-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019955-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019955-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019955-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019955-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019955-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019955-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019955-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019955-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019955-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019955-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019955-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019955-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019955-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019955-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019955-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019955-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019955-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019955-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019955-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019955-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019955-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019955-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019955-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019955-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019955-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019955-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019955-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019955-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019955-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019955-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019955-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019955-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019955-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019955-002	AB	1	`74a2ff9319b5…`

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DESMOPRESSIN ACETATE	.1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
XB13HYU18U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
833008	Internal RxNorm lookup
849515	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
c01048e8-d28f-4085-9c37-3d5d48395a77	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bde14c5d-9a3e-43bd-a8e6-0fb00287bdac	Product name	6	20250127
64db728f-18f9-4c58-ba09-60fd6f75f709	Product name	2	20190613
aa3ade84-795a-4f84-bfdf-ebe397f656f5	Product name	1	20190402
d8c9f9fc-e302-45b4-9b21-a802f2592402	Product name	1	20180810
4bbcef53-5c79-462a-b7ba-cff48fe1fb5a	Product name	1	20171129
74cda04a-3bd1-4535-800b-d9b9265e3211	Product name	2	20171129
50d55b09-49b8-f134-6bdc-eb6402b911dc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69918-101-01	Desmopressin Acetate	100 in 1 BOTTLE	TABLET	100		8
69918-101-01	Desmopressin Acetate	1 in 1 CARTON	TABLET	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69918-101-01	EA - Each	69918-101	31941b4b-0148-423c-9d8c-e6df10b0c157	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Desmopressin Acetate	ACTIVE INGREDIENT	XB13HYU18U	DESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]	1
desmopressin	ACTIVE MOIETY	ENR1LLB0FP	DESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]	1
Lactose	INACTIVE INGREDIENT	J2B2A4N98G	DESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	DESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]	1
Povidones	INACTIVE INGREDIENT	FZ989GH94E	DESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]	1
Starch, Potato	INACTIVE INGREDIENT	8I089SAH3T	DESMOPRESSIN ACETATE TABLET [AMRING PHARMACEUTICALS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69918-101	DESMOPRESSIN ACETATE TABLET [NORDIC PHARMA, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20241210_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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desmopressin Acetate	DESMOPRESSIN ACETATE	Bryant Ranch Prepack	52133714-37d1-458d-9839-f0bd206711ea	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019955 application number: NDA019955
Desmopressin Acetate	DESMOPRESSIN ACETATE	Nordic Pharma, Inc.	c01048e8-d28f-4085-9c37-3d5d48395a77	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019955 application number: NDA019955 ndc (product): 69918-101
DDAVP	DESMOPRESSIN ACETATE	Ferring Pharmaceuticals Inc.	6d55baa9-2b62-469c-93ae-3909ab249332	2021-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019955 application number: NDA019955

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XB13HYU18U	DESMOPRESSIN ACETATE	62357-86-2	DESMOPRESSIN ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
849515	desmopressin acetate 0.1 MG Oral Tablet	PSN	c01048e8-d28f-4085-9c37-3d5d48395a77	8
833008	desmopressin acetate 0.2 MG Oral Tablet	PSN	c01048e8-d28f-4085-9c37-3d5d48395a77	8
849515	desmopressin acetate 0.1 MG Oral Tablet	SCD	c01048e8-d28f-4085-9c37-3d5d48395a77	8
833008	desmopressin acetate 0.2 MG Oral Tablet	SCD	c01048e8-d28f-4085-9c37-3d5d48395a77	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69918-101-01	69918010101	1 BOTTLE in 1 CARTON (69918-101-01) / 100 TABLET in 1 BOTTLE	1 bottle	2015-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desmopressin Acetate Tablets Rx only	Nordic Pharma, Inc. \| Ferring International Center S.A.	2024-12-06	HUMAN PRESCRIPTION DRUG LABEL	8