Home NDC 55566-2300 DDAVP
Product NDC 55566-2300
11-digit product format 555662300
Labeler code 55566
Product ID 55566-2300_8837d5af-4cd2-4274-a30d-db28acc86364
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desmopressin Acetate
Dosage form INJECTION
Route INTRAVENOUS
Labeler Ferring Pharmaceuticals Inc.
Application NDA018938
Marketing category NDA
Marketing start 1984-05-01
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018938-001 DDAVP DESMOPRESSIN ACETATE 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 N018938-002 DDAVP DESMOPRESSIN ACETATE 0.015MG/ML INJECTABLE / INJECTION 1995-04-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018938-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018938-001 DDAVP 0.004MG/ML INJECTABLE / INJECTION AP RLD, RS 1984-03-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018938-002 DDAVP 0.015MG/ML INJECTABLE / INJECTION 1995-04-25 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DDAVP
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESMOPRESSIN ACETATE 4 ug/mL
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 849501 Internal RxNorm lookup 849503 Internal RxNorm lookup 1723232 Internal RxNorm lookup 1723234 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55566-2300-0 DDAVP 1 in 1 CARTON INJECTION 1 15 55566-2300-0 DDAVP 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55566-2300 DDAVP (DESMOPRESSIN ACETATE) INJECTION [FERRING PHARMACEUTICALS INC.] 15 Current NDC, Legacy NDC, 2 package rows 20221002_651f6fee-a2c7-431b-8d5d-58b156c72244.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Desmopressin Acetate DESMOPRESSIN ACETATE Nordic Pharma, Inc. 29df0492-f7ef-47bb-aa67-4ef9e5c2846f 2025-10-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018938 application number: NDA018938 Desmopressin Acetate DESMOPRESSIN ACETATE Nordic Pharma, Inc. 10b29aa2-274e-4c29-bccd-424bd3761758 2025-10-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018938 application number: NDA018938 Desmopressin Acetate DESMOPRESSIN ACETATE Nordic Pharma, Inc. 131fd4d8-48ca-4c1f-8165-848dc0a4d511 2025-07-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018938 application number: NDA018938 DDAVP DESMOPRESSIN ACETATE Ferring Pharmaceuticals Inc. 651f6fee-a2c7-431b-8d5d-58b156c72244 2022-09-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018938 application number: NDA018938 ndc (product): 55566-2300
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55566-2300-0 55566230000 1 VIAL, MULTI-DOSE in 1 CARTON (55566-2300-0) / 10 mL in 1 VIAL, MULTI-DOSE 1984-05-01 0000-00-00 No No Current