Morphine sulfate

Product NDC: 63304-758
11-digit product format: 633040758
Labeler code: 63304
Product ID: 63304-758_4d15b836-54c7-2f40-e063-6294a90a68a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: morphine sulfate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA078761
Marketing category: ANDA
Marketing start: 2012-05-11
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078761-001	MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11
A078761-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11
A078761-003	MORPHINE SULFATE	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11
A078761-004	MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11
A078761-005	MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A078761-001	AB
A078761-002	AB
A078761-003	AB
A078761-004	AB
A078761-005	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 6 · 205 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
2026-02-19 14:30 UTC	2026-02	A078761-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078761-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078761-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078761-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078761-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078761-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078761-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078761-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078761-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078761-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2012-05-11	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078761-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078761-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078761-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078761-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078761-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078761-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078761-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078761-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078761-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078761-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078761-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078761-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078761-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078761-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078761-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078761-005	AB	1	`5bbf6a4d5a75…`

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	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
736c9b80-682c-4cda-bf18-61b18de0bd39	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
63304-758-01	Morphine sulfate	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	13
63304-758-03	Morphine sulfate	10 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	10	13
63304-758-05	Morphine sulfate	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500	13
63304-758-50	Morphine sulfate	50 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	50	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-758-01	EA - Each	63304-758	a5a6744b-f38c-41a8-9f38-1d7606eabe22	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MORPHINE SULFATE	ACTIVE INGREDIENT	X3P646A2J0	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
MORPHINE	ACTIVE MOIETY	76I7G6D29C	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [RANBAXY PHARMACEUTICALS INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-758	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]	12	Current NDC, Legacy NDC, 4 package rows	20231220_736c9b80-682c-4cda-bf18-61b18de0bd39.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	595243fe-a4b1-479a-99d6-a084a4181891	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Sun Pharmaceutical Industries, Inc.	736c9b80-682c-4cda-bf18-61b18de0bd39	2026-03-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761 ndc (product): 63304-758
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	07993f6c-146b-4728-a2da-6e93089f78ff	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	3a89d0ca-4ff8-4bdc-8ea8-9ad591ce7226	2026-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	47ea2424-ce2f-4b3b-b393-da1886e7a383	2025-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	2f15f27b-95ed-4cc8-8937-eae07917a6dd	2024-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	20af0f0e-45cc-4795-97ef-90b659575b34	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	3e310662-16e8-4179-883e-efbca736b14d	2024-08-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	7f65fa22-c3fc-4413-8a07-2c6be621b7bf	2024-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	fd98b881-5466-457b-b5af-f102aec61546	2024-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	9a1ca529-8268-4be3-b03f-b2f2238cc9dc	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	fb9f929b-8c5a-442b-9695-9d3d45272a5e	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	73a39ce5-b2ab-47b9-8860-796f1d5bc8d8	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761
Morphine sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	ad08cd86-3825-4e77-bbe8-f6333a9ca9d7	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078761 application number: ANDA078761

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	7f65fa22-c3fc-4413-8a07-2c6be621b7bf	105
891893	morphine sulfate 60 MG Extended Release Oral Tablet	SCD	7f65fa22-c3fc-4413-8a07-2c6be621b7bf	105
891893	MS 60 MG Extended Release Oral Tablet	SY	7f65fa22-c3fc-4413-8a07-2c6be621b7bf	105
891893	morphine sulfate 60 MG Extended Release Oral Tablet	PSN	3e310662-16e8-4179-883e-efbca736b14d	104
891893	morphine sulfate 60 MG Extended Release Oral Tablet	SCD	3e310662-16e8-4179-883e-efbca736b14d	104
891893	MS 60 MG Extended Release Oral Tablet	SY	3e310662-16e8-4179-883e-efbca736b14d	104
891893	morphine sulfate 60 MG Extended Release Oral Tablet	PSN	47ea2424-ce2f-4b3b-b393-da1886e7a383	103
891893	morphine sulfate 60 MG Extended Release Oral Tablet	SCD	47ea2424-ce2f-4b3b-b393-da1886e7a383	103
891893	MS 60 MG Extended Release Oral Tablet	SY	47ea2424-ce2f-4b3b-b393-da1886e7a383	103
891874	morphine sulfate 100 MG Extended Release Oral Tablet	PSN	736c9b80-682c-4cda-bf18-61b18de0bd39	13
891881	morphine sulfate 15 MG Extended Release Oral Tablet	PSN	736c9b80-682c-4cda-bf18-61b18de0bd39	13
892646	morphine sulfate 200 MG Extended Release Oral Tablet	PSN	736c9b80-682c-4cda-bf18-61b18de0bd39	13
891888	morphine sulfate 30 MG Extended Release Oral Tablet	PSN	736c9b80-682c-4cda-bf18-61b18de0bd39	13
891893	morphine sulfate 60 MG Extended Release Oral Tablet	PSN	736c9b80-682c-4cda-bf18-61b18de0bd39	13
891874	morphine sulfate 100 MG Extended Release Oral Tablet	SCD	736c9b80-682c-4cda-bf18-61b18de0bd39	13
891881	morphine sulfate 15 MG Extended Release Oral Tablet	SCD	736c9b80-682c-4cda-bf18-61b18de0bd39	13
892646	morphine sulfate 200 MG Extended Release Oral Tablet	SCD	736c9b80-682c-4cda-bf18-61b18de0bd39	13
891888	morphine sulfate 30 MG Extended Release Oral Tablet	SCD	736c9b80-682c-4cda-bf18-61b18de0bd39	13
891893	morphine sulfate 60 MG Extended Release Oral Tablet	SCD	736c9b80-682c-4cda-bf18-61b18de0bd39	13
891874	MS 100 MG Extended Release Oral Tablet	SY	736c9b80-682c-4cda-bf18-61b18de0bd39	13
891881	MS 15 MG Extended Release Oral Tablet	SY	736c9b80-682c-4cda-bf18-61b18de0bd39	13
892646	MS 200 MG Extended Release Oral Tablet	SY	736c9b80-682c-4cda-bf18-61b18de0bd39	13
891888	MS 30 MG Extended Release Oral Tablet	SY	736c9b80-682c-4cda-bf18-61b18de0bd39	13
891893	MS 60 MG Extended Release Oral Tablet	SY	736c9b80-682c-4cda-bf18-61b18de0bd39	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63304-758-01	63304075801	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-758-01)	2012-05-11	0000-00-00	No	No	Current
63304-758-03	63304075803	10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-758-03)	2012-05-11	0000-00-00	No	No	Current
63304-758-05	63304075805	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-758-05)	2012-05-11	0000-00-00	No	No	Current
63304-758-50	63304075850	50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-758-50)	2012-05-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Morphine sulfate	Sun Pharmaceutical Industries, Inc. \| Ohm Laboratories Inc. \| Noramco, Inc.	2026-03-15	HUMAN PRESCRIPTION DRUG LABEL	13
Morphine sulfate	Bryant Ranch Prepack	2025-07-30	HUMAN PRESCRIPTION DRUG LABEL	103
Morphine sulfate	Bryant Ranch Prepack	2024-08-05	HUMAN PRESCRIPTION DRUG LABEL	104
Morphine sulfate	Bryant Ranch Prepack	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL	105