Morphine Sulfate

Product NDC: 17856-0517
11-digit product format: 178560517
Labeler code: 17856
Product ID: 17856-0517_6e52f354-e4bd-4fed-b733-14d48b06cd97
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: SOLUTION
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: NDA022195
Marketing category: NDA
Marketing start: 2008-03-17
Marketing end: 0000-00-00
Substance: MORPHINE SULFATE
Active strength: 100 mg/5mL
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17856-0517		I	Inactivated by FDA	2026-08-11
excluded package	package	17856-0517	17856-0517-1	I	Inactivated by FDA	2026-08-11
excluded package	package	17856-0517	17856-0517-2	I	Inactivated by FDA	2026-08-11
excluded package	package	17856-0517	17856-0517-3	I	Inactivated by FDA	2026-08-11
excluded package	package	17856-0517	17856-0517-4	I	Inactivated by FDA	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 · 45 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0517-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0517-2	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0517-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0517-4	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0517-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0517-2	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0517-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0517-4	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0517-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0517-2	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0517-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0517-4	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0517-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0517-2	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0517-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0517-4	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0517-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0517-2	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0517-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0517-4	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0517-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0517-2	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0517-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0517-4	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0517-4	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0517-2	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0517-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0517-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0517-4	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0517-2	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0517-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0517-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0517-4	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0517-2	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0517-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0517-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022195-001	MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17
N022195-002	MORPHINE SULFATE	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17
N022195-003	MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N022195-001	AA
N022195-002	AA
N022195-003	AA

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 4 · 123 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	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		RLD	2008-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 122 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	N022195-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022195-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022195-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022195-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022195-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022195-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022195-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022195-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022195-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022195-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022195-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022195-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022195-002	AA	1	`8072bd15b7f6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-001	NPP	2024-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-002	NPP	2024-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-001	NPP	2024-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-002	NPP	2024-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-001	NPP	2024-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-002	NPP	2024-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-001	NPP	2024-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-002	NPP	2024-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022195-001	NPP	2024-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022195-002	NPP	2024-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-001	NPP	2024-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-002	NPP	2024-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-001	NPP	2024-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-002	NPP	2024-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-001	NPP	2024-06-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-002	NPP	2024-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022195-001	NPP	2024-06-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022195-002	NPP	2024-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022195-001	NPP	2024-06-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022195-002	NPP	2024-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022195-001	NPP	2024-06-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022195-002	NPP	2024-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022195-001	NPP	2024-06-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022195-002	NPP	2024-06-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022195-001	NPP	2024-06-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022195-002	NPP	2024-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022195-001	NPP	2024-06-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022195-002	NPP	2024-06-02	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022195-001	NPP	2024-06-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022195-002	NPP	2024-06-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022195-001	NPP	2024-06-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022195-002	NPP	2024-06-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022195-001	NPP	2024-06-02	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022195-002	NPP	2024-06-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022195-001	NPP	2024-06-02	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022195-002	NPP	2024-06-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022195-001	NPP	2024-06-02	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022195-002	NPP	2024-06-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022195-001	NPP	2024-06-02	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022195-002	NPP	2024-06-02	`a67488948f0b…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
89941d4c-522d-cee0-b273-43cfa7ef6d35	Product name	4	20250516
f15f9e76-db42-8a50-218a-5ef5affa58da	Product name	4	20240216
944b0689-73f4-6a2f-c654-1180896353c0	Product name	4	20220210
67e166c6-23d4-4709-b77d-5ca6182dcae0	Product name	1	20180830
c573a64c-fe17-2eac-fbcb-788868b4ff6b	Product name	9	20180619
7c1819cf-69a0-41dc-aeaa-a820729bc959	Product name	1	20170406
7a68fc31-10e5-df04-67e0-3a613a2d4d2e	Product name	5	20161114
175682a8-c657-45a2-9dfb-c565306b03c8	Product name	1	20160112
b73dadd0-1b4a-4f88-956f-a2be216c8fad	Product name	1	20151123
4c272b1c-87fc-ebc0-994d-ac28b1e0416e	Product name	1	20140508
7a537f54-d322-5e54-a3a2-035d3e21c3c6	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
17856-0517-1	2025-01-30	These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-2	2025-01-30	These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-3	2025-01-30	These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-4	2025-01-30	These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-1	2023-06-15	These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-2	2023-06-15	These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-3	2023-06-15	These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-4	2023-06-15	These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-1	2023-01-30	These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-2	2023-01-30	These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-3	2023-01-30	These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941
17856-0517-4	2023-01-30	These highlights do not include all the information needed to use MORPHINE SULFATE ORAL SOLUTION safely and effectively. See full prescribing information for MORPHINE SULFATE ORAL SOLUTION. MORPHINE SULFATE oral solution, for oral use CII Initial U.S. Approval: 1941

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-0517-1	Morphine Sulfate	60 in 1 BOX, UNIT-DOSE	SOLUTION	60	4
17856-0517-2	Morphine Sulfate	120 in 1 BOX, UNIT-DOSE	SOLUTION	120	4
17856-0517-3	Morphine Sulfate	120 in 1 BOX, UNIT-DOSE	SOLUTION	120	4
17856-0517-4	Morphine Sulfate	120 in 1 BOX, UNIT-DOSE	SOLUTION	120	4
17856-0517-5	Morphine Sulfate	0.25 mL in 1 SYRINGE	SOLUTION	0.25	4
17856-0517-6	Morphine Sulfate	1.0 mL in 1 SYRINGE	SOLUTION	1.0	4
17856-0517-7	Morphine Sulfate	0.25 mL in 1 SYRINGE	SOLUTION	0.25	4
17856-0517-8	Morphine Sulfate	1 mL in 1 SYRINGE	SOLUTION	1	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0517	MORPHINE SULFATE SOLUTION [ATLANTIC BIOLOGICALS CORP.]	4	Legacy NDC, 8 package rows	20230616_839923b4-4b4c-4745-baa5-4d27d4dbb5e7.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	6654b91e-3b3f-4062-ac65-a2a70f942da4	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	bb6b3439-9f0c-45f5-bf6f-c7a971af0a8f	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	76966c05-df75-4072-ae99-97e42f91ab75	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	67f0ee8d-696e-4c08-9007-3df0e3988bad	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	Precision Dose Inc.	8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	ca359246-4674-4b32-b8b2-673d32b7112f	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	ae57637e-a86a-4ea5-9c68-47d98153d41a	2026-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	9f1ba2a2-d8ac-4f59-a587-fe413e56dcdb	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	PAI Holdings, LLC dba PAI Pharma	6e32b869-31c7-48c1-98ae-b21bd28151d7	2024-11-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	cc50d3c1-b4c8-4edc-9aa0-844d2fed45fb	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
892625	morphine sulfate 20 MG in 1 mL Concentrate for Oral Solution	PSN	839923b4-4b4c-4745-baa5-4d27d4dbb5e7	4
892625	morphine sulfate 20 MG/ML Oral Solution	SCD	839923b4-4b4c-4745-baa5-4d27d4dbb5e7	4
892625	morphine sulfate 10 MG per 0.5 ML Concentrate for Oral Solution	SY	839923b4-4b4c-4745-baa5-4d27d4dbb5e7	4
892625	morphine sulfate 100 MG per 5 ML Concentrate for Oral Solution	SY	839923b4-4b4c-4745-baa5-4d27d4dbb5e7	4
892625	morphine sulfate 20 MG/ML Concentrate for Oral Solution	SY	839923b4-4b4c-4745-baa5-4d27d4dbb5e7	4
892625	MS 20 MG/ML Oral Solution	SY	839923b4-4b4c-4745-baa5-4d27d4dbb5e7	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0517-1	17856051701	60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0517-1) > .25 mL in 1 SYRINGE	60 syringe	2021-01-07	0000-00-00	No	No	Current
17856-0517-2	17856051702	120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0517-2) > 1 mL in 1 SYRINGE	120 syringe	2021-01-07	0000-00-00	No	No	Current
17856-0517-3	17856051703	120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0517-3) > .25 mL in 1 SYRINGE	120 syringe	2021-01-07	0000-00-00	No	No	Current
17856-0517-4	17856051704	120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0517-4) > 1 mL in 1 SYRINGE	120 syringe	2021-03-10	0000-00-00	No	No	Current
17856-0517-5	17856051705	0.25 mL in 1 SYRINGE	0.25 ml					Historical
17856-0517-6	17856051706	1.0 mL in 1 SYRINGE	1.0 ml					Historical
17856-0517-7	17856051707	0.25 mL in 1 SYRINGE	0.25 ml					Historical
17856-0517-8	17856051708	1 mL in 1 SYRINGE	1 ml					Historical