Morphine Sulfate

Product NDC: 52959-406
11-digit product format: 529590406
Labeler code: 52959
Product ID: 52959-406_a0844f71-fb93-4a00-9908-dad2df9fdae7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA074862
Marketing category: ANDA
Marketing start: 2011-01-14
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: 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-406		I	Inactivated by FDA	2026-08-10
excluded package	package	52959-406	52959-406-02	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-406	52959-406-30	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-406	52959-406-60	I	Inactivated by FDA	2026-08-10
excluded package	package	52959-406	52959-406-90	I	Inactivated by FDA	2026-08-10

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 · 110 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	52959-406-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-406-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-406-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-406-02	`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	52959-406-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-406-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-406-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-406-02	`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	52959-406-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-406-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-406-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-406-02	`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	52959-406-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-406-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-406-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-406-02	`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	52959-406-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-406-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-406-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-406-02	`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	52959-406-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-406-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-406-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-406-02	`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	52959-406-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-406-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-406-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-406-02	`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	52959-406-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-406-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-406-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-406-02	`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	52959-406-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-406-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-406-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-406-02	`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	52959-406-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-406-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-406-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-406-02	`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	52959-406-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-406-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-406-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-406-02	`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	52959-406-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-406-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-406-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-406-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	TE codes	Approval date
A074862-001	MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07
A074862-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07
A074862-003	MORPHINE SULFATE	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A074862-001	AB
A074862-002	AB
A074862-003	AB

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 · 123 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	A074862-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074862-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074862-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074862-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074862-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074862-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074862-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074862-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074862-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074862-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074862-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074862-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074862-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074862-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074862-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074862-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074862-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074862-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074862-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074862-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074862-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074862-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074862-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074862-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074862-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074862-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074862-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074862-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074862-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074862-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074862-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074862-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074862-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074862-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074862-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074862-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074862-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074862-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074862-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074862-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-07	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074862-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074862-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074862-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074862-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074862-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074862-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074862-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074862-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074862-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074862-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074862-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074862-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074862-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074862-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074862-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074862-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074862-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074862-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074862-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074862-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074862-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074862-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074862-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074862-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074862-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074862-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074862-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074862-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074862-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074862-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074862-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074862-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074862-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074862-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074862-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074862-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074862-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074862-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074862-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074862-001	AB	1	`8072bd15b7f6…`

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, Related label table
NDC	Related label
52959-406-02	Morphine Sulfate Extended-Release Tablets CII 15 mg 30 mg 60 mg 100 mg* 200 mg*
52959-406-30	Morphine Sulfate Extended-Release Tablets CII 15 mg 30 mg 60 mg 100 mg* 200 mg*
52959-406-60	Morphine Sulfate Extended-Release Tablets CII 15 mg 30 mg 60 mg 100 mg* 200 mg*
52959-406-90	Morphine Sulfate Extended-Release Tablets CII 15 mg 30 mg 60 mg 100 mg* 200 mg*

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-406-02	Morphine Sulfate	120 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	120	2
52959-406-30	Morphine Sulfate	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	30	2
52959-406-60	Morphine Sulfate	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	60	2
52959-406-90	Morphine Sulfate	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-406-02	EA - Each	52959-406	a1b45dad-ae5d-4ca3-916d-13732ab56950	1	2012-07-24
52959-406-30	EA - Each	52959-406	3fde45a2-a05b-4139-8719-c5b46fe2ee13	1	2012-07-24
52959-406-60	EA - Each	52959-406	8b2919db-2ea3-4b6b-999e-7185f32d7a91	1	2012-07-24
52959-406-90	EA - Each	52959-406	edf45211-7ac0-45d2-8355-92400c4f3df9	1	2012-07-24

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 [H.J. HARKINS COMPANY, INC.]	2
MORPHINE	ACTIVE MOIETY	76I7G6D29C	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]	2
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]	2
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-406	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [H.J. HARKINS COMPANY, INC.]	2	Legacy NDC, 4 package rows	20111214_73e60510-751a-419c-82bb-c958e61e495e.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate Extended Release	MORPHINE SULFATE	Major Pharmaceuticals	dbb37dfd-0196-45f7-b9ca-393f56cf1d28	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074862 application number: ANDA074862
Morphine Sulfate Extended Release	MORPHINE SULFATE	Rhodes Pharmaceuticals LLC	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074862 application number: ANDA074862
Morphine Sulfate ER	MORPHINE SULFATE	Bryant Ranch Prepack	872ceecb-1f14-7a43-7451-e4650a01fbd9	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074862 application number: ANDA074862
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	cc3b491c-a206-3027-54f0-f87c0dd40a7f	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074862 application number: ANDA074862
Morphine Sulfate Extended Release	MORPHINE SULFATE	American Health Packaging	f915420d-981d-455b-b4cf-67c8e201a136	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074862 application number: ANDA074862

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
891881	morphine sulfate 15 MG Extended Release Oral Tablet	PSN	73e60510-751a-419c-82bb-c958e61e495e	2
891888	morphine sulfate 30 MG Extended Release Oral Tablet	PSN	73e60510-751a-419c-82bb-c958e61e495e	2
891881	morphine sulfate 15 MG Extended Release Oral Tablet	SCD	73e60510-751a-419c-82bb-c958e61e495e	2
891888	morphine sulfate 30 MG Extended Release Oral Tablet	SCD	73e60510-751a-419c-82bb-c958e61e495e	2
891881	MS 15 MG Extended Release Oral Tablet	SY	73e60510-751a-419c-82bb-c958e61e495e	2
891888	MS 30 MG Extended Release Oral Tablet	SY	73e60510-751a-419c-82bb-c958e61e495e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-406-02	52959040602	120 in 1 BOTTLE, PLASTIC	Historical
52959-406-30	52959040630	30 in 1 BOTTLE, PLASTIC	Historical
52959-406-60	52959040660	60 in 1 BOTTLE, PLASTIC	Historical
52959-406-90	52959040690	90 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Morphine Sulfate Extended-Release Tablets CII 15 mg 30 mg 60 mg 100 mg* 200 mg*	H.J. Harkins Company, Inc. \| Rhodes Pharmaceuticals L.P. \| Purdue Pharmaceuticals L.P.	2011-12-13	HUMAN PRESCRIPTION DRUG LABEL	2