MORPHINE SULFATE

Product NDC: 0406-8380
11-digit product format: 004068380
Labeler code: 0406
Product ID: 0406-8380_6873cac9-e7d5-4db2-851d-528268b483e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MORPHINE SULFATE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: SpecGx LLC
Application: ANDA076412
Marketing category: ANDA
Marketing start: 2003-07-31
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076412-001	MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31
A076412-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31
A076412-003	MORPHINE SULFATE	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A076412-001	AB
A076412-002	AB
A076412-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A076412-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076412-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076412-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076412-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076412-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076412-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076412-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076412-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076412-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076412-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076412-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076412-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076412-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076412-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076412-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076412-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076412-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076412-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076412-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076412-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076412-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076412-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076412-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076412-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076412-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076412-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076412-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076412-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076412-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076412-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076412-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076412-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076412-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076412-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076412-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076412-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076412-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076412-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076412-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076412-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2003-07-31	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076412-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076412-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076412-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076412-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076412-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076412-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076412-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076412-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076412-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076412-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076412-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076412-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076412-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076412-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076412-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076412-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076412-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076412-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076412-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076412-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076412-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076412-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076412-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076412-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076412-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076412-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076412-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076412-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076412-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076412-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076412-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076412-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076412-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076412-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076412-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076412-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076412-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076412-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076412-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076412-001	AB	1	`1e350fbaab3a…`

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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
891874	Internal RxNorm lookup
891881	Internal RxNorm lookup
891888	Internal RxNorm lookup
891893	Internal RxNorm lookup
892646	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
533034fd-c8e7-495b-8874-0db41bd1e65a	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
0406-8380-01	MORPHINE SULFATE	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	38
0406-8380-23	MORPHINE SULFATE	1 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	1	38
0406-8380-62	MORPHINE SULFATE	100 in 1 BLISTER PACK	TABLET, EXTENDED RELEASE	100	38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0406-8380-01	EA - Each	0406-8380	51fd738a-7a75-4406-a88b-59e2f6689b1b	1	2012-07-24
0406-8380-23	EA - Each	0406-8380	66d2985a-8065-435c-b870-cad30029b35c	1	2013-03-03
0406-8380-62	EA - Each	0406-8380	e63f2f5e-3ab6-4b42-afe5-84d0c32ee450	1	2012-07-24

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 [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	359
MORPHINE	ACTIVE MOIETY	76I7G6D29C	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	359
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	359
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	359
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	359
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	359
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	359
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	359
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	359
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	359
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	359
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	359
MORPHINE SULFATE	ACTIVE INGREDIENT	X3P646A2J0	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
MORPHINE	ACTIVE MOIETY	76I7G6D29C	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	MORPHINE SULFATE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]	19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0406-8380	MORPHINE SULFATE TABLET, EXTENDED RELEASE [SPECGX LLC]	38	Current NDC, Legacy NDC, 3 package rows	20240724_533034fd-c8e7-495b-8874-0db41bd1e65a.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	SpecGx LLC	533034fd-c8e7-495b-8874-0db41bd1e65a	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076412 application number: ANDA076412 ndc (product): 0406-8380

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	4bf994a4-6cc5-4941-8a81-6cf4c7ee235a	359
891893	morphine sulfate 60 MG Extended Release Oral Tablet	SCD	4bf994a4-6cc5-4941-8a81-6cf4c7ee235a	359
891893	MS 60 MG Extended Release Oral Tablet	SY	4bf994a4-6cc5-4941-8a81-6cf4c7ee235a	359
891874	morphine sulfate 100 MG Extended Release Oral Tablet	PSN	533034fd-c8e7-495b-8874-0db41bd1e65a	38
891881	morphine sulfate 15 MG Extended Release Oral Tablet	PSN	533034fd-c8e7-495b-8874-0db41bd1e65a	38
892646	morphine sulfate 200 MG Extended Release Oral Tablet	PSN	533034fd-c8e7-495b-8874-0db41bd1e65a	38
891888	morphine sulfate 30 MG Extended Release Oral Tablet	PSN	533034fd-c8e7-495b-8874-0db41bd1e65a	38
891893	morphine sulfate 60 MG Extended Release Oral Tablet	PSN	533034fd-c8e7-495b-8874-0db41bd1e65a	38
891874	morphine sulfate 100 MG Extended Release Oral Tablet	SCD	533034fd-c8e7-495b-8874-0db41bd1e65a	38
891881	morphine sulfate 15 MG Extended Release Oral Tablet	SCD	533034fd-c8e7-495b-8874-0db41bd1e65a	38
892646	morphine sulfate 200 MG Extended Release Oral Tablet	SCD	533034fd-c8e7-495b-8874-0db41bd1e65a	38
891888	morphine sulfate 30 MG Extended Release Oral Tablet	SCD	533034fd-c8e7-495b-8874-0db41bd1e65a	38
891893	morphine sulfate 60 MG Extended Release Oral Tablet	SCD	533034fd-c8e7-495b-8874-0db41bd1e65a	38
891874	MS 100 MG Extended Release Oral Tablet	SY	533034fd-c8e7-495b-8874-0db41bd1e65a	38
891881	MS 15 MG Extended Release Oral Tablet	SY	533034fd-c8e7-495b-8874-0db41bd1e65a	38
892646	MS 200 MG Extended Release Oral Tablet	SY	533034fd-c8e7-495b-8874-0db41bd1e65a	38
891888	MS 30 MG Extended Release Oral Tablet	SY	533034fd-c8e7-495b-8874-0db41bd1e65a	38
891893	MS 60 MG Extended Release Oral Tablet	SY	533034fd-c8e7-495b-8874-0db41bd1e65a	38

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0406-8380-01	00406838001	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0406-8380-01)	2003-07-31	0000-00-00	No	No	Current
0406-8380-23	00406838023	1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0406-8380-23)	2003-07-31	0000-00-00	No	No	Current
0406-8380-62	00406838062	100 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0406-8380-62)	2003-07-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MORPHINE SULFATE	SpecGx LLC	2023-12-01	HUMAN PRESCRIPTION DRUG LABEL	38
MORPHINE SULFATE ER 60 MG	Lake Erie Medical DBA Quality Care Products LLC \| Mallinckrodt Inc	2010-08-19	HUMAN PRESCRIPTION DRUG LABEL	359