Morphine sulfate

Product NDC: 63629-1089
11-digit product format: 636291089
Labeler code: 63629
Product ID: 63629-1089_5bfcacf9-13d1-41c2-aa7c-ad3d59643c8e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: morphine sulfate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078761
Marketing category: ANDA
Marketing start: 2012-05-11
Substance: MORPHINE SULFATE
Active strength: 60 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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63629-1089		D	Discontinued by firm		2026-08-11
excluded package	package	63629-1089	63629-1089-1	D	Discontinued by firm		2026-08-11

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 · 24 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	63629-1089-1	`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	63629-1089-1	`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	63629-1089-1	`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	63629-1089-1	`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	63629-1089-1	`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	63629-1089-1	`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	63629-1089-1	`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	63629-1089-1	`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	63629-1089-1	`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	63629-1089-1	`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	63629-1089-1	`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	63629-1089-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078761-001	MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11
A078761-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11
A078761-003	MORPHINE SULFATE	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11
A078761-004	MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11
A078761-005	MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A078761-001	AB
A078761-002	AB
A078761-003	AB
A078761-004	AB
A078761-005	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 6 · 205 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	A078761-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078761-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078761-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078761-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078761-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078761-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078761-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078761-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078761-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078761-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A078761-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078761-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078761-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078761-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078761-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078761-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078761-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078761-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078761-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078761-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-005	AB	1	`5bbf6a4d5a75…`

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	60 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
891893	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
3e310662-16e8-4179-883e-efbca736b14d	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-1089-1	Morphine sulfate	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1089-1	EA - Each	63629-1089	dc218765-f8ce-4b75-9fd3-9cefb77e5b04	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-1089	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 1 package rows	20240806_3e310662-16e8-4179-883e-efbca736b14d.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	595243fe-a4b1-479a-99d6-a084a4181891	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Sun Pharmaceutical Industries, Inc.	736c9b80-682c-4cda-bf18-61b18de0bd39	2026-03-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	07993f6c-146b-4728-a2da-6e93089f78ff	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	3a89d0ca-4ff8-4bdc-8ea8-9ad591ce7226	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	47ea2424-ce2f-4b3b-b393-da1886e7a383	2025-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	2f15f27b-95ed-4cc8-8937-eae07917a6dd	2024-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	20af0f0e-45cc-4795-97ef-90b659575b34	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	3e310662-16e8-4179-883e-efbca736b14d	2024-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761 ndc (product): 63629-1089
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	7f65fa22-c3fc-4413-8a07-2c6be621b7bf	2024-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	fd98b881-5466-457b-b5af-f102aec61546	2024-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	9a1ca529-8268-4be3-b03f-b2f2238cc9dc	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	fb9f929b-8c5a-442b-9695-9d3d45272a5e	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	73a39ce5-b2ab-47b9-8860-796f1d5bc8d8	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	ad08cd86-3825-4e77-bbe8-f6333a9ca9d7	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761

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
891893	morphine sulfate 60 MG Extended Release Oral Tablet	PSN	3e310662-16e8-4179-883e-efbca736b14d	104
891893	morphine sulfate 60 MG Extended Release Oral Tablet	SCD	3e310662-16e8-4179-883e-efbca736b14d	104
891893	MS 60 MG Extended Release Oral Tablet	SY	3e310662-16e8-4179-883e-efbca736b14d	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1089-1	63629108901	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-1089-1)	2012-05-11	0000-00-00	No	No	Current