VAPRISOL DEXTROSE IN PLASTIC CONTAINER

Product NDC: 66220-160
11-digit product format: 662200160
Labeler code: 66220
Product ID: 66220-160_55d8e04a-9757-4708-9ff0-827d686adc1d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: conivaptan hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Cumberland Pharmaceuticals Inc.
Application: NDA021697
Marketing category: NDA
Marketing start: 2008-10-08
Marketing end: 0000-00-00
Substance: CONIVAPTAN HYDROCHLORIDE
Active strength: 20 mg/100mL
Pharmacologic classes: Vasopressin Receptor Antagonists [MoA],Vasopressin Receptor Antagonist [EPC],Cytochrome P450 3A Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66220-160		D	Discontinued by firm		2026-08-10
excluded package	package	66220-160	66220-160-10	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66220-160-10	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66220-160-10	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66220-160-10	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66220-160-10	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66220-160-10	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66220-160-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66220-160-10	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66220-160-10	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66220-160-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66220-160-10	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66220-160-10	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66220-160-10	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	66220-160-10	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021697-001	VAPRISOL	CONIVAPTAN HYDROCHLORIDE	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS			2005-12-29
N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	CONIVAPTAN HYDROCHLORIDE	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS		RLD, RS	2008-10-08

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021697-001	VAPRISOL	20MG/4ML (5MG/ML)	INJECTABLE / INTRAVENOUS		2005-12-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021697-002	VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER	20MG/100ML (0.2MG/ML)	INJECTABLE / INTRAVENOUS	RLD, RS	2008-10-08	`782e0a99824c…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021697-001	5723606	2019-12-15	U-868	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021697-001	5723606	2019-12-15	U-698	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021697-002	5723606	2019-12-15	U-868	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021697-002	5723606	2019-12-15	U-698	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021697-001	5723606	2019-12-15	U-868	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021697-001	5723606	2019-12-15	U-698	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021697-002	5723606	2019-12-15	U-868	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021697-002	5723606	2019-12-15	U-698	Drug substance, Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021697-001	5723606	2019-12-15	U-868	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021697-001	5723606	2019-12-15	U-698	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021697-002	5723606	2019-12-15	U-868	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021697-002	5723606	2019-12-15	U-698	Drug substance, Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021697-001	5723606	2019-12-15	U-868	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021697-001	5723606	2019-12-15	U-698	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021697-002	5723606	2019-12-15	U-868	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021697-002	5723606	2019-12-15	U-698	Drug substance, Drug product	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66220-160-10	2023-12-22	C162847	48780-1	e4f33bdf-a45c-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use VAPRISOL safely and effectively. See full prescribing information for VAPRISOL. VAPRISOL ® (conivaptan hydrochloride) injection, for intravenous use Initial U.S. Approval: 2005
66220-160-10	2022-07-29	C162847	48780-1	e4f33bdf-a45c-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use VAPRISOL safely and effectively. See full prescribing information for VAPRISOL. VAPRISOL ® (conivaptan hydrochloride) injection, for intravenous use Initial U.S. Approval: 2005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66220-160-10	ML - Milliliter	66220-160	99157cbd-35db-4e51-bebb-4d9fead2d1a0	1	2015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
conivaptan hydrochloride	ACTIVE INGREDIENT	75L57R6X36	VAPRISOL DEXTROSE IN PLASTIC CONTAINER (CONIVAPTAN HYDROCHLORIDE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]	3
conivaptan	ACTIVE MOIETY	0NJ98Y462X	VAPRISOL DEXTROSE IN PLASTIC CONTAINER (CONIVAPTAN HYDROCHLORIDE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]	3
dextrose	INACTIVE INGREDIENT	IY9XDZ35W2	VAPRISOL DEXTROSE IN PLASTIC CONTAINER (CONIVAPTAN HYDROCHLORIDE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]	3
lactic acid	INACTIVE INGREDIENT	33X04XA5AT	VAPRISOL DEXTROSE IN PLASTIC CONTAINER (CONIVAPTAN HYDROCHLORIDE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
75L57R6X36	CONIVAPTAN HYDROCHLORIDE	168626-94-6	CONIVAPTAN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66220-160-10	66220016010	1 BAG in 1 BOX (66220-160-10) > 1 POUCH in 1 BAG > 100 mL in 1 POUCH	1 bag	2008-10-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VAPRISOL DEXTROSE IN PLASTIC CONTAINER	Cumberland Pharmaceuticals Inc.	2023-12-21	HUMAN PRESCRIPTION DRUG LABEL	6