MORPHINE SULFATE

Product NDC: 60760-893
11-digit product format: 607600893
Labeler code: 60760
Product ID: 60760-893_57ee00f2-7974-6312-e063-6394a90a678e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MORPHINE SULFATE
Dosage form: TABLET
Route: ORAL
Labeler: St. Mary's Medical Park Pharmacy
Application: ANDA212451
Marketing category: ANDA
Marketing start: 2026-07-30
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

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: 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
892582	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
57ee014e-744e-65e1-e063-6394a90a8c93	Available on FDA.report

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 ndc (product): 60760-893
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60760-893-60	60760089360	60 TABLET in 1 BOTTLE, GLASS (60760-893-60)	60 tablet	2026-07-30	No	No	Current