MORPHINE SULFATE

Product NDC: 67877-671
11-digit product format: 678770671
Labeler code: 67877
Product ID: 67877-671_2d263950-4148-405d-b582-13857ac88044
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MORPHINE SULFATE
Dosage form: TABLET
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA212451
Marketing category: ANDA
Marketing start: 2021-02-11
Substance: MORPHINE SULFATE
Active strength: 30 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 20 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
2025-04-01 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	67877-671-01	`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	67877-671-01	`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	67877-671-01	`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	67877-671-01	`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	67877-671-01	`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	67877-671-01	`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	67877-671-01	`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	67877-671-01	`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	67877-671-01	`367a005e9d99…`	`383a685ebd0f…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	67877-671-01	`fb8cb913e6d1…`	`eb8c232b6be0…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A212451-001	MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET / ORAL	AB		2020-12-03
A212451-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET / ORAL	AB		2020-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212451-001	AB
A212451-002	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 2 · 76 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
2026-09-14 22:38:34	2026-08	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212451-001	MORPHINE SULFATE	15MG	TABLET / ORAL	AB	2020-12-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212451-002	MORPHINE SULFATE	30MG	TABLET / ORAL	AB	2020-12-03	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212451-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212451-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212451-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212451-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212451-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212451-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212451-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212451-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212451-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212451-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212451-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212451-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212451-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212451-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212451-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212451-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212451-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212451-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212451-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212451-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212451-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212451-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212451-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212451-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212451-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212451-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212451-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212451-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212451-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212451-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212451-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212451-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212451-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212451-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212451-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212451-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212451-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212451-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212451-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212451-002	AB	1	`bb7c543d1eb4…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A212451-001	CGT	2021-08-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212451-002	CGT	2021-08-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212451-001	CGT	2021-08-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212451-002	CGT	2021-08-10	`87673890dc5c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	30 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
892582	Internal RxNorm lookup
892672	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
07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a	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#

Effective, Related label table
Effective	Related label
2025-05-13	These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941
2025-05-13	These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941
2024-07-30	These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941
2024-07-30	These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941
2022-09-16	These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941
2022-09-16	These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941
2022-07-29	These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941
2022-07-29	These highlights do not include all the information needed to use MORPHINE SULFATE TABLETS safely and effectively. See full prescribing information for MORPHINE SULFATE TABLETS. MORPHINE SULFATE tablets, for oral use CII Initial U.S. Approval: 1941

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67877-671-01	MORPHINE SULFATE	100 in 1 BOTTLE	TABLET	100		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-671-01	EA - Each	67877-671	4d3a7a8f-522c-44b3-8501-8a5f2ed0fd29	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-671	MORPHINE SULFATE TABLET [ASCEND LABORATORIES, LLC]	10	Current NDC, Legacy NDC, 1 package rows	20250515_07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a.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	MORPHINE SULFATE	St. Mary's Medical Park Pharmacy	57ee014e-744e-65e1-e063-6394a90a8c93	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212451 application number: ANDA212451
MORPHINE SULFATE	MORPHINE SULFATE	Bryant Ranch Prepack	d1b0b4ac-69d9-44bf-b7a3-229bd89b9fd6	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212451 application number: ANDA212451
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	d66d0cfb-9bfe-490c-90ee-49481c567e85	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212451 application number: ANDA212451
MORPHINE SULFATE	MORPHINE SULFATE	Ascend Laboratories, LLC	07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212451 application number: ANDA212451 ndc (product): 67877-671
MORPHINE SULFATE	MORPHINE SULFATE	Bryant Ranch Prepack	905cd842-2c86-4318-a6c4-92f49de145b3	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212451 application number: ANDA212451

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
892672	morphine sulfate 30 MG Oral Tablet	PSN	d1b0b4ac-69d9-44bf-b7a3-229bd89b9fd6	102
892672	morphine sulfate 30 MG Oral Tablet	SCD	d1b0b4ac-69d9-44bf-b7a3-229bd89b9fd6	102
892672	MS 30 MG Oral Tablet	SY	d1b0b4ac-69d9-44bf-b7a3-229bd89b9fd6	102
892582	morphine sulfate 15 MG Oral Tablet	PSN	07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a	11
892672	morphine sulfate 30 MG Oral Tablet	PSN	07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a	11
892582	morphine sulfate 15 MG Oral Tablet	SCD	07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a	11
892672	morphine sulfate 30 MG Oral Tablet	SCD	07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a	11
892582	MS 15 MG Oral Tablet	SY	07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a	11
892672	MS 30 MG Oral Tablet	SY	07593aa4-f2c4-4d6e-b186-ab2a4ecaa38a	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-671-01	67877067101	100 TABLET in 1 BOTTLE (67877-671-01)	100 tablet	2021-02-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MORPHINE SULFATE	Bryant Ranch Prepack	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	102
MORPHINE SULFATE	Ascend Laboratories, LLC \| Aavis Pharmaceuticals	2025-10-10	Human Prescription Drug Label	11
MORPHINE SULFATE	Bryant Ranch Prepack	2025-06-16	HUMAN PRESCRIPTION DRUG LABEL	104
MORPHINE SULFATE	RedPharm Drug	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	1
MORPHINE SULFATE	Quality Care Products, LLC	2024-03-14	Human Prescription Drug Label	4