Morphine Sulfate

Product NDC: 58177-340
11-digit product format: 581770340
Labeler code: 58177
Product ID: 58177-340_44b9cb00-c457-4cc3-99e3-0db1be101fcd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: ETHEX Corporation
Application: ANDA077855
Marketing category: ANDA
Marketing start: 2009-01-01
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: E
Listing certified through: 2017-12-31
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	58177-340		I	Inactivated by FDA	2026-08-17
excluded package	package	58177-340	58177-340-04	I	Inactivated by FDA	2026-08-17
excluded package	package	58177-340	58177-340-09	I	Inactivated by FDA	2026-08-17
excluded package	package	58177-340	58177-340-11	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 2 · 88 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	58177-340-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58177-340-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58177-340-09	`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	58177-340-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58177-340-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58177-340-09	`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	58177-340-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58177-340-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58177-340-09	`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	58177-340-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58177-340-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58177-340-09	`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	58177-340-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58177-340-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58177-340-09	`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	58177-340-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58177-340-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58177-340-09	`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	58177-340-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58177-340-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58177-340-09	`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	58177-340-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58177-340-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58177-340-09	`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	58177-340-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58177-340-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58177-340-09	`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	58177-340-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58177-340-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58177-340-09	`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	58177-340-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58177-340-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58177-340-09	`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	58177-340-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58177-340-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58177-340-09	`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	58177-340-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58177-340-11	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58177-340-09	`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	58177-340-04	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58177-340-11	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58177-340-09	`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	58177-340-04	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58177-340-11	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58177-340-09	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A077855-001	MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL			2007-09-27
A077855-002	MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL			2007-09-27

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 · 84 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
2026-08-18 06:07:40	2026-07	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-09-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077855-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077855-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2007-09-27	`bb7c543d1eb4…`

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	A077855-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077855-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077855-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077855-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077855-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077855-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077855-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077855-002	AB	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
58177-340-04	2019-10-21	C162847	48780-1	956f9ecf-d260-621f-e053-dbdaa90a74ad	CII Morphine Sulfate Extended-Release Tablets 15 mg, 30 mg, 60 mg, 100 mg* and 200 mg*
58177-340-09	2019-10-21	C162847	48780-1	956f9ecf-d260-621f-e053-dbdaa90a74ad	CII Morphine Sulfate Extended-Release Tablets 15 mg, 30 mg, 60 mg, 100 mg* and 200 mg*
58177-340-11	2019-10-21	C162847	48780-1	956f9ecf-d260-621f-e053-dbdaa90a74ad	CII Morphine Sulfate Extended-Release Tablets 15 mg, 30 mg, 60 mg, 100 mg* and 200 mg*

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58177-340-04	Morphine Sulfate	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	5
58177-340-09	Morphine Sulfate	1000 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	1000	5
58177-340-11	Morphine Sulfate	100 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	100	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MORPHINE SULFATE	ACTIVE INGREDIENT	X3P646A2J0	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
MORPHINE	ACTIVE MOIETY	76I7G6D29C	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58177-340	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [ETHEX CORPORATION]	5	Legacy NDC, 3 package rows	20100521_1a2c9474-fab6-41a0-844d-d6bd5e6a4341.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
891874	morphine sulfate 100 MG Extended Release Oral Tablet	PSN	1a2c9474-fab6-41a0-844d-d6bd5e6a4341	5
891881	morphine sulfate 15 MG Extended Release Oral Tablet	PSN	1a2c9474-fab6-41a0-844d-d6bd5e6a4341	5
892646	morphine sulfate 200 MG Extended Release Oral Tablet	PSN	1a2c9474-fab6-41a0-844d-d6bd5e6a4341	5
891888	morphine sulfate 30 MG Extended Release Oral Tablet	PSN	1a2c9474-fab6-41a0-844d-d6bd5e6a4341	5
891893	morphine sulfate 60 MG Extended Release Oral Tablet	PSN	1a2c9474-fab6-41a0-844d-d6bd5e6a4341	5
891874	morphine sulfate 100 MG Extended Release Oral Tablet	SCD	1a2c9474-fab6-41a0-844d-d6bd5e6a4341	5
891881	morphine sulfate 15 MG Extended Release Oral Tablet	SCD	1a2c9474-fab6-41a0-844d-d6bd5e6a4341	5
892646	morphine sulfate 200 MG Extended Release Oral Tablet	SCD	1a2c9474-fab6-41a0-844d-d6bd5e6a4341	5
891888	morphine sulfate 30 MG Extended Release Oral Tablet	SCD	1a2c9474-fab6-41a0-844d-d6bd5e6a4341	5
891893	morphine sulfate 60 MG Extended Release Oral Tablet	SCD	1a2c9474-fab6-41a0-844d-d6bd5e6a4341	5
891874	MS 100 MG Extended Release Oral Tablet	SY	1a2c9474-fab6-41a0-844d-d6bd5e6a4341	5
891881	MS 15 MG Extended Release Oral Tablet	SY	1a2c9474-fab6-41a0-844d-d6bd5e6a4341	5
892646	MS 200 MG Extended Release Oral Tablet	SY	1a2c9474-fab6-41a0-844d-d6bd5e6a4341	5
891888	MS 30 MG Extended Release Oral Tablet	SY	1a2c9474-fab6-41a0-844d-d6bd5e6a4341	5
891893	MS 60 MG Extended Release Oral Tablet	SY	1a2c9474-fab6-41a0-844d-d6bd5e6a4341	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
58177-340-04	58177034004	100 in 1 BOTTLE	Historical
58177-340-09	58177034009	1000 in 1 BOTTLE	Historical
58177-340-11	58177034011	100 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CII Morphine Sulfate Extended-Release Tablets 15 mg, 30 mg, 60 mg, 100 mg* and 200 mg*	ETHEX Corporation \| KV Pharmaceutical \| KV Pharmaceutical (EC IV) \| KV Pharmaceutical (Westport) \| KV Pharmaceutical (EC I) \| KV Pharmaceutical (Metro 2)	2010-05-14	HUMAN PRESCRIPTION DRUG LABEL	5