Morphine Sulfate

Product NDC: 63629-4483
11-digit product format: 636294483
Labeler code: 63629
Product ID: 63629-4483_a6e982b8-e597-4955-9387-b1404883682b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA074862
Marketing category: ANDA
Marketing start: 2011-01-14
Substance: MORPHINE SULFATE
Active strength: 15 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 33 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
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63629-4483-5	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63629-4483-6	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63629-4483-0	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63629-4483-7	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63629-4483-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63629-4483-2	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63629-4483-8	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63629-4483-3	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63629-4483-4	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	63629-4483-9	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4483-5	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4483-6	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4483-0	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4483-7	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4483-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4483-2	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4483-8	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4483-3	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4483-4	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	63629-4483-9	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4483-5	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4483-6	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4483-0	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4483-7	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4483-1	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4483-2	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4483-8	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4483-3	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4483-4	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-4483-9	`9bebd1f3094a…`	`5416666fcb17…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Morphine Sulfate
Brand name suffix: ER
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MORPHINE SULFATE	15 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
891881	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
872ceecb-1f14-7a43-7451-e4650a01fbd9	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, Related label table
NDC	Effective	Related label
63629-4483-0	2022-01-03	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-1	2022-01-03	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-2	2022-01-03	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-3	2022-01-03	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-4	2022-01-03	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-5	2022-01-03	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-6	2022-01-03	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-7	2022-01-03	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-8	2022-01-03	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-9	2022-01-03	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-0	2020-01-31	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-1	2020-01-31	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-2	2020-01-31	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-3	2020-01-31	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-4	2020-01-31	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-5	2020-01-31	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-6	2020-01-31	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-7	2020-01-31	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-8	2020-01-31	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 for oral use, CII Initial U.S. Approval: 1941
63629-4483-9	2020-01-31	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 for oral use, CII Initial U.S. Approval: 1941

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-4483-0	Morphine SulfateER	26 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	26	1017
63629-4483-1	Morphine SulfateER	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	1017
63629-4483-2	Morphine SulfateER	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	1017
63629-4483-3	Morphine SulfateER	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	1017
63629-4483-4	Morphine SulfateER	120 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	120	1017
63629-4483-5	Morphine SulfateER	40 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	40	1017
63629-4483-6	Morphine SulfateER	14 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	14	1017
63629-4483-7	Morphine SulfateER	15 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	15	1017
63629-4483-8	Morphine SulfateER	20 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	20	1017
63629-4483-9	Morphine SulfateER	84 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	84	1017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-4483-1	EA - Each	63629-4483	8a788c68-ffb6-4934-bc1a-f5dbe7c251d5	1	2012-07-24
63629-4483-2	EA - Each	63629-4483	ca615cf5-708e-4bd0-b8ad-a8ac11d0bf07	1	2012-07-24
63629-4483-3	EA - Each	63629-4483	bebc71a1-452d-4606-b6fa-bb571d386455	1	2012-07-24
63629-4483-4	EA - Each	63629-4483	3cb0deef-7253-49e4-ac38-7c70fb1b16a1	1	2013-02-13
63629-4483-5	EA - Each	63629-4483	a2056a05-38ad-490a-b6ed-02a06eee79ea	1	2013-02-13

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 [BRYANT RANCH PREPACK]	4
MORPHINE	ACTIVE MOIETY	76I7G6D29C	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	4
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	4
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	4
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-4483	MORPHINE SULFATE ER (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1016	Current NDC, Legacy NDC, 10 package rows	20240524_872ceecb-1f14-7a43-7451-e4650a01fbd9.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 ndc (product): 63629-4483
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	872ceecb-1f14-7a43-7451-e4650a01fbd9	1017
891881	morphine sulfate 15 MG Extended Release Oral Tablet	SCD	872ceecb-1f14-7a43-7451-e4650a01fbd9	1017
891881	MS 15 MG Extended Release Oral Tablet	SY	872ceecb-1f14-7a43-7451-e4650a01fbd9	1017

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-4483-0	63629448300	26 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-0)	2022-01-03	0000-00-00	No	No	Current
63629-4483-1	63629448301	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-1)	2011-04-20	0000-00-00	No	No	Current
63629-4483-2	63629448302	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-2)	2011-04-14	0000-00-00	No	No	Current
63629-4483-3	63629448303	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-3)	2011-07-11	0000-00-00	No	No	Current
63629-4483-4	63629448304	120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-4)	2022-01-03	0000-00-00	No	No	Current
63629-4483-5	63629448305	40 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-5)	2022-01-03	0000-00-00	No	No	Current
63629-4483-6	63629448306	14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-6)	2012-08-13	0000-00-00	No	No	Current
63629-4483-7	63629448307	15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-7)	2014-04-29	0000-00-00	No	No	Current
63629-4483-8	63629448308	20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-8)	2022-01-03	0000-00-00	No	No	Current
63629-4483-9	63629448309	84 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4483-9)	2015-04-15	0000-00-00	No	No	Current