Morphine Sulfate

Product NDC: 63629-4514
Requested package NDC: 63629-4514-2
11-digit product format: 636294514
Labeler code: 63629
Product ID: 63629-4514_8a6f34df-6bd8-4ea5-839f-43cd2b0ef5c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA074769
Marketing category: ANDA
Marketing start: 2011-01-14
Marketing end: 0000-00-00
Substance: MORPHINE SULFATE
Active strength: 100 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-4514	63629-4514-2	D	Discontinued by firm		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 1 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2021-12-27 23:28 UTC · source 2021-12-27	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

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

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
A074769-001	MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-07-02
A074769-002	MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-07-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A074769-001	AB
A074769-002	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 3 · 82 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	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A074769-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074769-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074769-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074769-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074769-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074769-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074769-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074769-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074769-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074769-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074769-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074769-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074769-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074769-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074769-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074769-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074769-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074769-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074769-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074769-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074769-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074769-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074769-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074769-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074769-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074769-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074769-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074769-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074769-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074769-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074769-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074769-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074769-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074769-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074769-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074769-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074769-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074769-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074769-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A074769-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4514-1	2022-02-16	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
63629-4514-2	2022-02-16	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
63629-4514-3	2022-02-16	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
63629-4514-1	2019-11-27	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
63629-4514-2	2019-11-27	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
63629-4514-3	2019-11-27	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-4514-1	EA - Each	63629-4514	2ae3cb84-9e17-407f-8274-d1168c539286	1	2015-10-02
63629-4514-2	EA - Each	63629-4514	53ffc099-bf8c-4317-a265-c016ab123b11	1	2015-10-02
63629-4514-3	EA - Each	63629-4514	9b0c453b-fbb7-4b71-899b-0c95f258b6d2	1	2015-10-02
63629-4514-4	EA - Each	63629-4514	9811e589-cd0d-4777-ba6e-b06153732ff1	1	2022-03-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MORPHINE SULFATE	ACTIVE INGREDIENT	X3P646A2J0	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
MORPHINE	ACTIVE MOIETY	76I7G6D29C	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1000

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 · 4 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): 074769 application number: ANDA074769
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): 074769 application number: ANDA074769
Morphine Sulfate Extended Release	MORPHINE SULFATE	Bryant Ranch Prepack	2dd52157-3121-41ed-abc2-99b269531e56	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074769 application number: ANDA074769
Morphine Sulfate Extended Release	MORPHINE SULFATE	Bryant Ranch Prepack	c94d9da6-7a12-44ee-a38f-3323ee27842c	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074769 application number: ANDA074769

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X3P646A2J0	MORPHINE SULFATE	6211-15-0	MORPHINE SULFATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-4514-2	63629451402	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-4514-2)	2011-06-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Morphine Sulfate Extended Release	Bryant Ranch Prepack	2022-02-08	HUMAN PRESCRIPTION DRUG LABEL	1001