Morphine Sulfate

Product NDC: 0115-1279
11-digit product format: 001151279
Labeler code: 0115
Product ID: 0115-1279_b2330bfc-8b32-421e-ade5-2076ee23cebb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MORPHINE SULFATE
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA200411
Marketing category: ANDA
Marketing start: 2016-04-12
Substance: MORPHINE SULFATE
Active strength: 50 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 44.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A200411-001	MORPHINE SULFATE	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12
A200411-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12
A200411-003	MORPHINE SULFATE	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12
A200411-004	MORPHINE SULFATE	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12
A200411-005	MORPHINE SULFATE	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12
A200411-006	MORPHINE SULFATE	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12
A200411-007	MORPHINE SULFATE	MORPHINE SULFATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2018-07-25

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 8 · 305 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A200411-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200411-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200411-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200411-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200411-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200411-006	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A200411-007	MORPHINE SULFATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2018-07-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A200411-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200411-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200411-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200411-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200411-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200411-006	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200411-007	MORPHINE SULFATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2018-07-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200411-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200411-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200411-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200411-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200411-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200411-006	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200411-007	MORPHINE SULFATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2018-07-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200411-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200411-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200411-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200411-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200411-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200411-006	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200411-007	MORPHINE SULFATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2018-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200411-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200411-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200411-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200411-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200411-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200411-006	MORPHINE SULFATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200411-007	MORPHINE SULFATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2018-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200411-001	MORPHINE SULFATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200411-002	MORPHINE SULFATE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200411-003	MORPHINE SULFATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200411-004	MORPHINE SULFATE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200411-005	MORPHINE SULFATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	2016-04-12	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 89 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200411-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200411-006	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200411-007	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200411-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200411-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200411-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200411-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200411-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200411-006	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200411-007	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200411-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200411-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200411-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200411-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200411-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200411-006	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200411-007	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200411-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200411-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200411-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200411-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200411-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200411-006	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200411-007	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200411-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200411-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200411-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200411-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200411-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200411-006	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200411-007	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200411-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200411-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200411-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200411-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200411-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200411-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200411-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200411-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200411-003	AB	1	`ea99ee380514…`

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	50 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 · 7 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
892345	Internal RxNorm lookup
892352	Internal RxNorm lookup
892554	Internal RxNorm lookup
892596	Internal RxNorm lookup
894801	Internal RxNorm lookup
894814	Internal RxNorm lookup
1303736	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
f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	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	SPL version
0115-1279-01	Morphine Sulfate	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	42
0115-1279-03	Morphine Sulfate	1000 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1000	42
0115-1279-08	Morphine Sulfate	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1279-01	EA - Each	0115-1279	dc99b6eb-2c9b-4cbc-9cb7-9879126e81ed	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-1279	MORPHINE SULFATE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	37	Current NDC, Legacy NDC, 3 package rows	20240215_f7e9a4b3-a2ee-4f0a-becd-6ef90867332b.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate	MORPHINE SULFATE	Amneal Pharmaceuticals of New York LLC	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	2025-11-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200411 application number: ANDA200411 ndc (product): 0115-1279

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
892554	morphine sulfate 100 MG Extended Release Oral Capsule	PSN	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
892596	morphine sulfate 20 MG Extended Release Oral Capsule	PSN	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
892345	morphine sulfate 30 MG Extended Release Oral Capsule	PSN	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
1303736	morphine sulfate 40 MG Extended Release Oral Capsule	PSN	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
894801	morphine sulfate 50 MG Extended Release Oral Capsule	PSN	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
892352	morphine sulfate 60 MG Extended Release Oral Capsule	PSN	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
894814	morphine sulfate 80 MG Extended Release Oral Capsule	PSN	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
892554	morphine sulfate 100 MG Extended Release Oral Capsule	SCD	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
892596	morphine sulfate 20 MG Extended Release Oral Capsule	SCD	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
892345	morphine sulfate 30 MG Extended Release Oral Capsule	SCD	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
1303736	morphine sulfate 40 MG Extended Release Oral Capsule	SCD	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
894801	morphine sulfate 50 MG Extended Release Oral Capsule	SCD	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
892352	morphine sulfate 60 MG Extended Release Oral Capsule	SCD	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
894814	morphine sulfate 80 MG Extended Release Oral Capsule	SCD	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
892352	morphine sulfate 60 MG 12-24 HR Extended Release Oral Capsule	SY	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
892554	MS 100 MG Extended Release Oral Capsule	SY	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
892596	MS 20 MG Extended Release Oral Capsule	SY	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
892345	MS 30 MG Extended Release Oral Capsule	SY	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
1303736	MS 40 MG Extended Release Oral Capsule	SY	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
894801	MS 50 MG Extended Release Oral Capsule	SY	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
892352	MS 60 MG Extended Release Oral Capsule	SY	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42
894814	MS 80 MG Extended Release Oral Capsule	SY	f7e9a4b3-a2ee-4f0a-becd-6ef90867332b	42

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-1279-01	00115127901	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1279-01)	2016-04-12	0000-00-00	No	No	Current
0115-1279-03	00115127903	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1279-03)	2016-04-12	0000-00-00	No	No	Current
0115-1279-08	00115127908	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1279-08)	2016-04-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Morphine Sulfate	Amneal Pharmaceuticals of New York LLC \| Amneal Pharmaceuticals of New York, LLC	2025-11-28	HUMAN PRESCRIPTION DRUG LABEL	42