Morphine Sulfate

Product NDC: 51862-617
11-digit product format: 518620617
Labeler code: 51862
Product ID: 51862-617_068fb771-cd6b-4e25-aa84-6dae2175d2cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: TABLET
Route: ORAL
Labeler: Mayne Pharma Inc
Application: ANDA207270
Marketing category: ANDA
Marketing start: 2022-01-14
Marketing end: 0000-00-00
Substance: MORPHINE SULFATE
Active strength: 30 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2023-12-31
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	51862-617		D	Discontinued by firm		2026-08-03
excluded package	package	51862-617	51862-617-01	D	Discontinued by firm		2026-08-03

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 · 18 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	51862-617-01	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	51862-617-01	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	51862-617-01	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	51862-617-01	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	51862-617-01	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	51862-617-01	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	51862-617-01	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	51862-617-01	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	51862-617-01	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207270-001	MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET / ORAL			2022-01-12
A207270-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET / ORAL			2022-01-12

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 2 · 64 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	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL		2022-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL		2022-01-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL		2022-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL		2022-01-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL		2022-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL		2022-01-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL		2022-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL		2022-01-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL		2022-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL		2022-01-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL		2022-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL		2022-01-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL		2022-01-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL		2022-01-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL		2022-01-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL		2022-01-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL		2022-01-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL		2022-01-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL		2022-01-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL		2022-01-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL		2022-01-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL		2022-01-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL		2022-01-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL		2022-01-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL		2022-01-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL		2022-01-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL		2022-01-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL		2022-01-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2022-01-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2022-01-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2022-01-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2022-01-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2022-01-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2022-01-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2022-01-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2022-01-12	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL		2022-01-12	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL		2022-01-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207270-001	MORPHINE SULFATE	15MG	TABLET / ORAL		2022-01-12	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A207270-002	MORPHINE SULFATE	30MG	TABLET / ORAL		2022-01-12	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207270-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207270-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207270-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207270-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207270-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207270-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207270-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207270-002	AB	1	`bb7c543d1eb4…`
2023-05-13 08:27 UTC	2023-05	A207270-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A207270-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207270-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A207270-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207270-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207270-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207270-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A207270-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207270-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A207270-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207270-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207270-002	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51862-617-01	2026-01-26	C162847	48780-1	2cef2736-82fe-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941
51862-617-01	2025-01-30	C162847	48780-1	2cef2736-82fe-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-617-01	EA - Each	51862-617	cfcbd705-6eac-4571-809e-add78d0c160e	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51862-617	MORPHINE SULFATE TABLET [MAYNE PHARMA COMMERCIAL LLC]	3	Legacy NDC	20230707_6c26431c-5ad1-4c79-9db6-1e8071b2c793.zip

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
51862-617-01	51862061701	100 TABLET in 1 BOTTLE (51862-617-01)	100 tablet	2022-01-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Morphine Sulfate	Mayne Pharma Commercial LLC \| Catalent Greenville, Inc.	2023-07-05	HUMAN PRESCRIPTION DRUG LABEL	3