Morphine Sulfate

Product NDC: 66689-033
11-digit product format: 666890033
Labeler code: 66689
Product ID: 66689-033_1df00599-930d-4545-afdf-fe083ca6741f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: SOLUTION
Route: ORAL
Labeler: VistaPharm, Inc.
Application: ANDA201947
Marketing category: ANDA
Marketing start: 2012-03-01
Marketing end: 0000-00-00
Substance: MORPHINE SULFATE
Active strength: 20 mg/5mL
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66689-033		D	Discontinued by firm	2026-08-11
excluded package	package	66689-033	66689-033-04	D	Discontinued by firm	2026-08-11
excluded package	package	66689-033	66689-033-16	D	Discontinued by firm	2026-08-11
excluded package	package	66689-033	66689-033-50	D	Discontinued by firm	2026-08-11

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66689-033-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66689-033-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66689-033-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66689-033-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66689-033-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66689-033-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66689-033-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66689-033-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66689-033-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66689-033-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66689-033-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66689-033-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66689-033-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66689-033-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66689-033-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66689-033-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66689-033-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66689-033-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66689-033-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66689-033-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66689-033-16	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66689-033-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66689-033-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66689-033-16	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66689-033-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66689-033-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66689-033-16	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66689-033-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66689-033-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66689-033-16	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66689-033-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66689-033-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66689-033-16	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66689-033-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66689-033-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66689-033-16	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A201947-001	MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL			2012-01-05
A201947-002	MORPHINE SULFATE	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL			2012-01-05

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	2012-01-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201947-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2012-01-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201947-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		2012-01-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A201947-002	AA	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A201947-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201947-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201947-002	AA	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66689-033-01	ML - Milliliter	66689-033	73dd4b47-4272-4f9a-a834-bb4d44278c39	1	2012-07-24
66689-033-04	ML - Milliliter	66689-033	932c7baf-96ae-4f11-8aa9-1448699d36b2	1	2012-07-24
66689-033-16	ML - Milliliter	66689-033	79f20e6c-49ad-44c9-8711-50f51274824d	1	2012-07-24
66689-033-50	ML - Milliliter	66689-033	197686aa-9a7a-44c0-b8fe-d5592ed88d15	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Morphine Sulfate	ACTIVE INGREDIENT	X3P646A2J0	MORPHINE SULFATE SOLUTION [VISTAPHARM INC.]	5
Morphine	ACTIVE MOIETY	76I7G6D29C	MORPHINE SULFATE SOLUTION [VISTAPHARM INC.]	5
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	MORPHINE SULFATE SOLUTION [VISTAPHARM INC.]	5
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	MORPHINE SULFATE SOLUTION [VISTAPHARM INC.]	5
FD&C Red NO. 40	INACTIVE INGREDIENT	WZB9127XOA	MORPHINE SULFATE SOLUTION [VISTAPHARM INC.]	5
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	MORPHINE SULFATE SOLUTION [VISTAPHARM INC.]	5
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	MORPHINE SULFATE SOLUTION [VISTAPHARM INC.]	5
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	MORPHINE SULFATE SOLUTION [VISTAPHARM INC.]	5
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	MORPHINE SULFATE SOLUTION [VISTAPHARM INC.]	5
Sorbitol	INACTIVE INGREDIENT	506T60A25R	MORPHINE SULFATE SOLUTION [VISTAPHARM INC.]	5
Water	INACTIVE INGREDIENT	059QF0KO0R	MORPHINE SULFATE SOLUTION [VISTAPHARM INC.]	5

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X3P646A2J0	MORPHINE SULFATE	6211-15-0	MORPHINE SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66689-033-04	66689003304	100 mL in 1 BOTTLE (66689-033-04)	100 ml	2012-03-01	0000-00-00	No	No	Current
66689-033-16	66689003316	500 mL in 1 BOTTLE (66689-033-16)	500 ml	2012-03-01	0000-00-00	No	No	Current
66689-033-50	66689003350	5 TRAY in 1 CASE (66689-033-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (66689-033-01)	5 tray	2012-03-01	0000-00-00	No	No	Current