Morphine Sulfate

Product NDC: 42858-805
11-digit product format: 428580805
Labeler code: 42858
Product ID: 42858-805_ccb2d4f4-3f19-40cd-9653-cec37213f8a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Rhodes Pharmaceuticals LLC
Application: ANDA074769
Marketing category: ANDA
Marketing start: 2011-01-14
Substance: MORPHINE SULFATE
Active strength: 200 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 42.

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
A074769-001	MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-07-02
A074769-002	MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB		1998-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074769-001	AB
A074769-002	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 3 · 84 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	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074769-001	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074769-002	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1998-07-02	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A074769-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074769-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074769-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074769-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074769-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074769-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074769-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074769-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074769-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074769-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074769-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074769-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074769-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074769-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074769-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074769-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074769-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074769-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074769-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074769-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074769-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074769-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074769-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074769-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074769-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074769-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074769-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074769-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074769-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074769-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074769-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074769-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074769-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074769-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074769-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074769-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074769-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074769-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074769-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074769-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Morphine Sulfate
Brand name suffix: Extended Release
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MORPHINE SULFATE	200 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
19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
42858-805-01	Morphine SulfateExtended Release	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED, EXTENDED RE	100		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42858-805-01	EA - Each	42858-805	770fbc7c-c330-4514-8c95-d06a56c303cc	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, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
MORPHINE	ACTIVE MOIETY	76I7G6D29C	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	7
MORPHINE SULFATE	ACTIVE INGREDIENT	X3P646A2J0	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
MORPHINE	ACTIVE MOIETY	76I7G6D29C	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42858-805	MORPHINE SULFATE EXTENDED RELEASE (MORPHINE SULFATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L. P.]	13	Current NDC, Legacy NDC, 1 package rows	20240120_19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate Extended Release	MORPHINE SULFATE	Major Pharmaceuticals	dbb37dfd-0196-45f7-b9ca-393f56cf1d28	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074769 application number: ANDA074769
Morphine Sulfate Extended Release	MORPHINE SULFATE	Rhodes Pharmaceuticals LLC	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074769 application number: ANDA074769 ndc (product): 42858-805
Morphine Sulfate Extended Release	MORPHINE SULFATE	Bryant Ranch Prepack	2dd52157-3121-41ed-abc2-99b269531e56	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074769 application number: ANDA074769
Morphine Sulfate Extended Release	MORPHINE SULFATE	Bryant Ranch Prepack	c94d9da6-7a12-44ee-a38f-3323ee27842c	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074769 application number: ANDA074769

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
892646	morphine sulfate 200 MG Extended Release Oral Tablet	PSN	2dd52157-3121-41ed-abc2-99b269531e56	104
892646	morphine sulfate 200 MG Extended Release Oral Tablet	SCD	2dd52157-3121-41ed-abc2-99b269531e56	104
892646	MS 200 MG Extended Release Oral Tablet	SY	2dd52157-3121-41ed-abc2-99b269531e56	104
892646	morphine sulfate 200 MG Extended Release Oral Tablet	PSN	c94d9da6-7a12-44ee-a38f-3323ee27842c	101
892646	morphine sulfate 200 MG Extended Release Oral Tablet	SCD	c94d9da6-7a12-44ee-a38f-3323ee27842c	101
892646	MS 200 MG Extended Release Oral Tablet	SY	c94d9da6-7a12-44ee-a38f-3323ee27842c	101
891874	morphine sulfate 100 MG Extended Release Oral Tablet	PSN	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	16
891881	morphine sulfate 15 MG Extended Release Oral Tablet	PSN	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	16
892646	morphine sulfate 200 MG Extended Release Oral Tablet	PSN	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	16
891888	morphine sulfate 30 MG Extended Release Oral Tablet	PSN	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	16
891893	morphine sulfate 60 MG Extended Release Oral Tablet	PSN	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	16
891874	morphine sulfate 100 MG Extended Release Oral Tablet	SCD	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	16
891881	morphine sulfate 15 MG Extended Release Oral Tablet	SCD	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	16
892646	morphine sulfate 200 MG Extended Release Oral Tablet	SCD	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	16
891888	morphine sulfate 30 MG Extended Release Oral Tablet	SCD	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	16
891893	morphine sulfate 60 MG Extended Release Oral Tablet	SCD	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	16
891874	MS 100 MG Extended Release Oral Tablet	SY	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	16
891881	MS 15 MG Extended Release Oral Tablet	SY	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	16
892646	MS 200 MG Extended Release Oral Tablet	SY	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	16
891888	MS 30 MG Extended Release Oral Tablet	SY	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	16
891893	MS 60 MG Extended Release Oral Tablet	SY	19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42858-805-01	42858080501	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-805-01)	2011-01-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Morphine Sulfate Extended Release	Rhodes Pharmaceuticals LLC \| Knoa Pharmaceuticals LLC	2026-05-04	HUMAN PRESCRIPTION DRUG LABEL	16
Morphine Sulfate Extended Release	Bryant Ranch Prepack	2026-04-14	HUMAN PRESCRIPTION DRUG LABEL	104
Morphine Sulfate Extended Release	Bryant Ranch Prepack	2026-04-03	HUMAN PRESCRIPTION DRUG LABEL	101
morphine sulfate extended release	Lake Erie Medical DBA Quality Care Products LLC	2019-10-30	HUMAN PRESCRIPTION DRUG LABEL	5