Morphine Sulfate

Product NDC: 51862-188
11-digit product format: 518620188
Labeler code: 51862
Product ID: 51862-188_d65d4561-fca0-4ac9-9406-119c00607bf6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Mayne Pharma Inc.
Application: ANDA205386
Marketing category: ANDA
Marketing start: 2016-11-01
Marketing end: 0000-00-00
Substance: MORPHINE SULFATE
Active strength: 100 mg/1
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	51862-188		D	Discontinued by firm		2026-08-03
excluded package	package	51862-188	51862-188-01	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	51862-188-01	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	51862-188-01	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	51862-188-01	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	51862-188-01	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	51862-188-01	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	51862-188-01	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	51862-188-01	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	51862-188-01	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	51862-188-01	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A205386-001	MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28
A205386-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28
A205386-003	MORPHINE SULFATE	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28
A205386-004	MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205386-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205386-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205386-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205386-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205386-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205386-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205386-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205386-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205386-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205386-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205386-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205386-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205386-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205386-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205386-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205386-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205386-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205386-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205386-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205386-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205386-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205386-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205386-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205386-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205386-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205386-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205386-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205386-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205386-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205386-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205386-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205386-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205386-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205386-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205386-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205386-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205386-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205386-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205386-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205386-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2016-10-28	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

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	A205386-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205386-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205386-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205386-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205386-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205386-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205386-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205386-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205386-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205386-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205386-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205386-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205386-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205386-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205386-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205386-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205386-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205386-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205386-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205386-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205386-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205386-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205386-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205386-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205386-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205386-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205386-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205386-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205386-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205386-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205386-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205386-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205386-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205386-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205386-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205386-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205386-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205386-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205386-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205386-004	AB	1	`c0c555d07b60…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51862-188-01	2026-01-26	C162847	48780-1	2cef2736-7dc0-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use Morphine sulfate extended-release tablets safely and effectively. See full prescribing information for Morphine sulfate extended-release tablets. Morphine sulfate extended-release tablets (morphine sulfate extended-release tablets), for oral use CII Initial U.S. Approval: 1941
51862-188-01	2025-01-30	C162847	48780-1	2cef2736-7dc0-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use Morphine sulfate extended-release tablets safely and effectively. See full prescribing information for Morphine sulfate extended-release tablets. Morphine sulfate extended-release tablets (morphine sulfate extended-release 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
51862-188-01	EA - Each	51862-188	b0b3319c-e50b-4ae0-a80c-7043245200eb	1	2016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51862-188	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [MAYNE PHARMA COMMERCIAL LLC]	8	Legacy NDC	20230707_053e3fd9-25fc-4b55-b683-63fb9d190dae.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	Marketing start	Marketing end	Sample	Exclude flag	Status
51862-188-01	51862018801	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51862-188-01)	2016-11-01	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.	2023-07-06	HUMAN PRESCRIPTION DRUG LABEL	8