DESMOPRESSIN ACETATE

Product NDC: 60505-0815
Requested package NDC: 60505-0815-0
11-digit product format: 605050815
Labeler code: 60505
Product ID: 60505-0815_f90935bd-bb23-2f9c-3271-8508e92d45c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DESMOPRESSIN ACETATE
Dosage form: SPRAY
Route: NASAL
Labeler: Apotex Corp.
Application: ANDA076703
Marketing category: ANDA
Marketing start: 2020-11-30
Substance: DESMOPRESSIN ACETATE
Active strength: 10 ug/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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	DESMOPRESSIN ACETATE	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076703-001	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 1 of 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB	RS	2005-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076703-001	DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)	0.01MG/SPRAY	SPRAY, METERED / NASAL	AB		2005-01-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076703-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076703-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076703-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076703-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076703-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076703-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076703-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076703-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076703-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076703-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076703-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076703-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076703-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076703-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076703-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076703-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076703-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076703-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076703-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076703-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076703-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076703-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076703-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076703-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076703-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076703-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076703-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076703-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076703-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076703-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076703-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076703-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076703-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076703-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076703-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076703-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076703-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076703-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076703-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076703-001	AB	1	`cb3db0bc1861…`

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	10 ug/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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
849506	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
1ac423b8-27a6-4cef-4a82-c50bf81b4f49	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
64db728f-18f9-4c58-ba09-60fd6f75f709	Product name	2	20190613
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
aa3ade84-795a-4f84-bfdf-ebe397f656f5	Product name	1	20190402
d8c9f9fc-e302-45b4-9b21-a802f2592402	Product name	1	20180810
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
4bbcef53-5c79-462a-b7ba-cff48fe1fb5a	Product name	1	20171129
74cda04a-3bd1-4535-800b-d9b9265e3211	Product name	2	20171129
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
50d55b09-49b8-f134-6bdc-eb6402b911dc	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60505-0815-0	2025-08-22	C162847	48780-1	3b156c62-3286-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use DESMOPRESSIN NASAL SPRAY safely and effectively. See full prescribing information for DESMOPRESSIN NASAL SPRAY. DESMOPRESSIN nasal spray Initial U.S. Approval: 1978
60505-0815-0	2025-07-29	C162847	48780-1	3b156c62-3286-fb37-e063-e6dba90a4e07	These highlights do not include all the information needed to use DESMOPRESSIN NASAL SPRAY safely and effectively. See full prescribing information for DESMOPRESSIN NASAL SPRAY. DESMOPRESSIN nasal spray Initial U.S. Approval: 1978

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-0815-0	DESMOPRESSIN ACETATE	1 in 1 CARTON	SPRAY	1		12
60505-0815-0	DESMOPRESSIN ACETATE	50 in 1 BOTTLE, SPRAY	SPRAY	50		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0815-0	ML - Milliliter	60505-0815	093d8eed-b031-4805-bd6d-ffc895f0d29e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DESMOPRESSIN ACETATE	ACTIVE INGREDIENT	XB13HYU18U	DESMOPRESSIN ACETATE SPRAY [APOTEX CORP.]	2
DESMOPRESSIN	ACTIVE MOIETY	ENR1LLB0FP	DESMOPRESSIN ACETATE SPRAY [APOTEX CORP.]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	DESMOPRESSIN ACETATE SPRAY [APOTEX CORP.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DESMOPRESSIN ACETATE SPRAY [APOTEX CORP.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	DESMOPRESSIN ACETATE SPRAY [APOTEX CORP.]	2
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE	INACTIVE INGREDIENT	70WT22SF4B	DESMOPRESSIN ACETATE SPRAY [APOTEX CORP.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DESMOPRESSIN ACETATE SPRAY [APOTEX CORP.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0815	DESMOPRESSIN ACETATE SPRAY [APOTEX CORP.]	11	Current NDC, Legacy NDC, 2 package rows	20240926_1ac423b8-27a6-4cef-4a82-c50bf81b4f49.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DESMOPRESSIN ACETATE	DESMOPRESSIN ACETATE	Apotex Corp.	1ac423b8-27a6-4cef-4a82-c50bf81b4f49	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076703 application number: ANDA076703 ndc (package): 60505-0815-0 ndc (product): 60505-0815 ndc11 (package): 60505081500

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
849506	desmopressin acetate 0.01 % Nasal Spray	PSN	1ac423b8-27a6-4cef-4a82-c50bf81b4f49	12
849506	desmopressin acetate 0.01 MG/ACTUAT Nasal Spray	SCD	1ac423b8-27a6-4cef-4a82-c50bf81b4f49	12
849506	desmopressin acetate 0.01 % Nasal Spray	SY	1ac423b8-27a6-4cef-4a82-c50bf81b4f49	12
849506	desmopressin acetate 10 MCG per 0.1 ML Nasal Spray	SY	1ac423b8-27a6-4cef-4a82-c50bf81b4f49	12
849506	desmopressin acetate 10 MCG/ACTUAT Nasal Spray	SY	1ac423b8-27a6-4cef-4a82-c50bf81b4f49	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0815-0	60505081500	1 BOTTLE, SPRAY in 1 CARTON (60505-0815-0) / 50 SPRAY in 1 BOTTLE, SPRAY	2020-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DESMOPRESSIN ACETATE	Bryant Ranch Prepack	2025-11-04	HUMAN PRESCRIPTION DRUG LABEL	102
DESMOPRESSIN ACETATE	Apotex Corp.	2025-08-22	HUMAN PRESCRIPTION DRUG LABEL	12