Morphine Sulfate

Product NDC: 17856-1170
11-digit product format: 178561170
Labeler code: 17856
Product ID: 17856-1170_c6dabf86-cc9e-4d2e-b357-192058d6f12b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: SOLUTION
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA205509
Marketing category: ANDA
Marketing start: 2018-07-09
Marketing end: 0000-00-00
Substance: MORPHINE SULFATE
Active strength: 10 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	17856-1170		I	Inactivated by FDA		2026-08-17
excluded package	package	17856-1170	17856-1170-1	I	Inactivated by FDA		2026-08-17

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 · 30 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	17856-1170-1	`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	17856-1170-1	`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	17856-1170-1	`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	17856-1170-1	`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	17856-1170-1	`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	17856-1170-1	`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	17856-1170-1	`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	17856-1170-1	`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	17856-1170-1	`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	17856-1170-1	`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	17856-1170-1	`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	17856-1170-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17856-1170-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-1170-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-1170-1	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A205509-001	MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	2018-04-17
A205509-002	MORPHINE SULFATE	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	2018-04-17
A205509-003	MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	2018-04-17

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205509-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	2018-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205509-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	2018-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205509-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	2018-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205509-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	2018-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205509-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	2018-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205509-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	2018-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205509-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	2018-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205509-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	2018-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205509-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	2018-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205509-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	2018-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205509-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	2018-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205509-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	2018-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205509-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	2018-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205509-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	2018-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205509-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	2018-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205509-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	2018-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205509-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	2018-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205509-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	2018-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205509-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	2018-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205509-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	2018-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205509-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	2018-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205509-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	2018-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205509-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	2018-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205509-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	2018-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205509-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	2018-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205509-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	2018-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205509-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	2018-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205509-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	2018-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205509-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	2018-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205509-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	2018-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205509-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	2018-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205509-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	2018-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205509-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	2018-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205509-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	2018-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205509-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	2018-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205509-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	2018-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205509-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	2018-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205509-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	2018-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205509-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	2018-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205509-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	2018-04-17	`1e350fbaab3a…`

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	A205509-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205509-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205509-003	AA	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A205509-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205509-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205509-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205509-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205509-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205509-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205509-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205509-002	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205509-003	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205509-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205509-002	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205509-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205509-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205509-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205509-003	AA	1	`ea99ee380514…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-1170-1	2023-01-30	C162847	48780-1	f386c649-b2ba-0266-e053-dadaa90a7c1a	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, CII Initial U.S. Approval: 1941

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-1170-1	Morphine Sulfate	120 in 1 BOX, UNIT-DOSE	SOLUTION	120		2
17856-1170-1	Morphine Sulfate	0.5 mL in 1 SYRINGE	SOLUTION	0.5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-1170	MORPHINE SULFATE SOLUTION [ATLANTIC BIOLOGICALS CORP.]	2	Legacy NDC, 2 package rows	20210121_bee55fcb-80a4-45dc-bd10-0127abf7cea0.zip

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
892589	morphine sulfate 10 MG in 5 mL Oral Solution	PSN	bee55fcb-80a4-45dc-bd10-0127abf7cea0	2
892589	morphine sulfate 2 MG/ML Oral Solution	SCD	bee55fcb-80a4-45dc-bd10-0127abf7cea0	2
892589	morphine sulfate 10 MG per 5 ML Oral Solution	SY	bee55fcb-80a4-45dc-bd10-0127abf7cea0	2
892589	MS 2 MG/ML Oral Solution	SY	bee55fcb-80a4-45dc-bd10-0127abf7cea0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-1170-1	17856117001	120 SYRINGE in 1 BOX, UNIT-DOSE (17856-1170-1) > .5 mL in 1 SYRINGE	120 syringe	2021-01-20	0000-00-00	No	No	Current