Morphine Sulfate

Product NDC: 42689-007
11-digit product format: 426890007
Labeler code: 42689
Product ID: 42689-007_863bb977-9d7b-4258-a6ff-3ed2eeefeb81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: morphine sulfate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Nortec Development Associates, Inc.
Application: ANDA203158
Marketing category: ANDA
Marketing start: 2009-04-07
Substance: MORPHINE SULFATE
Active strength: 50 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	42689-007		I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42689-007	42689-007-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A203158-001	MORPHINE SULFATE	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04
A203158-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04
A203158-003	MORPHINE SULFATE	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04
A203158-004	MORPHINE SULFATE	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04
A203158-005	MORPHINE SULFATE	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04
A203158-006	MORPHINE SULFATE	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04

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 6 · 204 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	A203158-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203158-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203158-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203158-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203158-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203158-006	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203158-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203158-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203158-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203158-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203158-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203158-006	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203158-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203158-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203158-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203158-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203158-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203158-006	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203158-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203158-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203158-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203158-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203158-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203158-006	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203158-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203158-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203158-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203158-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203158-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203158-006	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203158-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203158-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203158-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203158-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203158-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203158-006	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203158-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203158-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203158-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203158-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2021-08-04	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A203158-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203158-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203158-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203158-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203158-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203158-006	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Morphine Sulfate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MORPHINE SULFATE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X3P646A2J0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
892345	Internal RxNorm lookup
892352	Internal RxNorm lookup
892554	Internal RxNorm lookup
892596	Internal RxNorm lookup
894801	Internal RxNorm lookup
894814	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	Available on FDA.report

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
42689-007-01	2023-01-24	C162847	48780-1	e4f33bdf-9e75-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use MORPHINE SULFATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MORPHINE SULFATE EXTENDED-RELEASE CAPSULES. MORPHINE SULFATE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 1941
42689-007-01	2022-07-29	C162847	48780-1	e4f33bdf-9e75-d8a0-e053-dadaa90a6e4e	These highlights do not include all the information needed to use MORPHINE SULFATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for MORPHINE SULFATE EXTENDED-RELEASE CAPSULES. MORPHINE SULFATE Extended-Release Capsules, for oral use, CII Initial U.S. Approval: 1941

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42689-007-01	Morphine Sulfate	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42689-007	MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC.]	15	Current NDC, Legacy NDC, 1 package rows	20231104_9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate	MORPHINE SULFATE	Nortec Development Associates, Inc.	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	2025-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203158 application number: ANDA203158 ndc (product): 42689-007

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
892554	morphine sulfate 100 MG Extended Release Oral Capsule	PSN	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
892596	morphine sulfate 20 MG Extended Release Oral Capsule	PSN	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
892345	morphine sulfate 30 MG Extended Release Oral Capsule	PSN	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
894801	morphine sulfate 50 MG Extended Release Oral Capsule	PSN	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
892352	morphine sulfate 60 MG Extended Release Oral Capsule	PSN	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
894814	morphine sulfate 80 MG Extended Release Oral Capsule	PSN	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
892554	morphine sulfate 100 MG Extended Release Oral Capsule	SCD	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
892596	morphine sulfate 20 MG Extended Release Oral Capsule	SCD	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
892345	morphine sulfate 30 MG Extended Release Oral Capsule	SCD	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
894801	morphine sulfate 50 MG Extended Release Oral Capsule	SCD	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
892352	morphine sulfate 60 MG Extended Release Oral Capsule	SCD	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
894814	morphine sulfate 80 MG Extended Release Oral Capsule	SCD	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
892352	morphine sulfate 60 MG 12-24 HR Extended Release Oral Capsule	SY	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
892554	MS 100 MG Extended Release Oral Capsule	SY	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
892596	MS 20 MG Extended Release Oral Capsule	SY	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
892345	MS 30 MG Extended Release Oral Capsule	SY	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
894801	MS 50 MG Extended Release Oral Capsule	SY	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
892352	MS 60 MG Extended Release Oral Capsule	SY	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16
894814	MS 80 MG Extended Release Oral Capsule	SY	9c1a5b8b-8faa-4ee0-80bd-853c239bb1c4	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42689-007-01	42689000701	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-007-01)	2009-04-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Morphine Sulfate	Nortec Development Associates, Inc. \| MPL Laboratories \| Alcami \| Sharp Corporation \| Mallinckrodt, Inc. \| Glatt Air Techniques, Inc. \| Acta Laboratories, Inc. \| SGS North America Inc.	2025-08-25	HUMAN PRESCRIPTION DRUG LABEL	16