Morphine Sulfate

Product NDC: 43386-543
Requested package NDC: 43386-543-05
11-digit product format: 433860543
Labeler code: 43386
Product ID: 43386-543_d4efe614-fe99-4cc7-b3ba-87c4e010efbd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Lupin Pharmaceuticals,Inc.
Application: ANDA203602
Marketing category: ANDA
Marketing start: 2015-12-16
Substance: MORPHINE SULFATE
Active strength: 100 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 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	Approval date
A203602-001	MORPHINE SULFATE	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	2015-12-16
A203602-002	MORPHINE SULFATE	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	2015-12-16
A203602-003	MORPHINE SULFATE	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	2015-12-16
A203602-004	MORPHINE SULFATE	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	2015-12-16
A203602-005	MORPHINE SULFATE	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	2015-12-16

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	A203602-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203602-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203602-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203602-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203602-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203602-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203602-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203602-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203602-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203602-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203602-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203602-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203602-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203602-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203602-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203602-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203602-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203602-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203602-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203602-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL		2015-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203602-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203602-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203602-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203602-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203602-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203602-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203602-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203602-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203602-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203602-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-001	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-002	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-003	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-004	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-005	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE / ORAL	AB	2015-12-16	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203602-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203602-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203602-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203602-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203602-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203602-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203602-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203602-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203602-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203602-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203602-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203602-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203602-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203602-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203602-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203602-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203602-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203602-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203602-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203602-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203602-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203602-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203602-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203602-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203602-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203602-004	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203602-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203602-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203602-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203602-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203602-004	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203602-005	AB	1	`301d65b070ca…`

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	100 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
d360a33f-6323-4b10-9e81-07e2813c2dbd	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
944b0689-73f4-6a2f-c654-1180896353c0	Product name	4	20220210
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
67e166c6-23d4-4709-b77d-5ca6182dcae0	Product name	1	20180830
c573a64c-fe17-2eac-fbcb-788868b4ff6b	Product name	9	20180619
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
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
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
4c272b1c-87fc-ebc0-994d-ac28b1e0416e	Product name	1	20140508
7a537f54-d322-5e54-a3a2-035d3e21c3c6	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43386-543-01	Morphine Sulfate	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		7
43386-543-05	Morphine Sulfate	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43386-543-01	EA - Each	43386-543	13f88463-e020-4184-bd33-595883c2be2d	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-543	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [LUPIN PHARMACEUTICALS,INC.]	7	Current NDC, Legacy NDC, 2 package rows	20241204_d360a33f-6323-4b10-9e81-07e2813c2dbd.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	Lupin Pharmaceuticals,Inc.	d360a33f-6323-4b10-9e81-07e2813c2dbd	2024-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203602 application number: ANDA203602 ndc (package): 43386-543-05 ndc (product): 43386-543 ndc11 (package): 43386054305

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
891874	morphine sulfate 100 MG Extended Release Oral Tablet	PSN	d360a33f-6323-4b10-9e81-07e2813c2dbd	7
891881	morphine sulfate 15 MG Extended Release Oral Tablet	PSN	d360a33f-6323-4b10-9e81-07e2813c2dbd	7
892646	morphine sulfate 200 MG Extended Release Oral Tablet	PSN	d360a33f-6323-4b10-9e81-07e2813c2dbd	7
891888	morphine sulfate 30 MG Extended Release Oral Tablet	PSN	d360a33f-6323-4b10-9e81-07e2813c2dbd	7
891893	morphine sulfate 60 MG Extended Release Oral Tablet	PSN	d360a33f-6323-4b10-9e81-07e2813c2dbd	7
891874	morphine sulfate 100 MG Extended Release Oral Tablet	SCD	d360a33f-6323-4b10-9e81-07e2813c2dbd	7
891881	morphine sulfate 15 MG Extended Release Oral Tablet	SCD	d360a33f-6323-4b10-9e81-07e2813c2dbd	7
892646	morphine sulfate 200 MG Extended Release Oral Tablet	SCD	d360a33f-6323-4b10-9e81-07e2813c2dbd	7
891888	morphine sulfate 30 MG Extended Release Oral Tablet	SCD	d360a33f-6323-4b10-9e81-07e2813c2dbd	7
891893	morphine sulfate 60 MG Extended Release Oral Tablet	SCD	d360a33f-6323-4b10-9e81-07e2813c2dbd	7
891874	MS 100 MG Extended Release Oral Tablet	SY	d360a33f-6323-4b10-9e81-07e2813c2dbd	7
891881	MS 15 MG Extended Release Oral Tablet	SY	d360a33f-6323-4b10-9e81-07e2813c2dbd	7
892646	MS 200 MG Extended Release Oral Tablet	SY	d360a33f-6323-4b10-9e81-07e2813c2dbd	7
891888	MS 30 MG Extended Release Oral Tablet	SY	d360a33f-6323-4b10-9e81-07e2813c2dbd	7
891893	MS 60 MG Extended Release Oral Tablet	SY	d360a33f-6323-4b10-9e81-07e2813c2dbd	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43386-543-05	43386054305	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43386-543-05)	2015-12-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Morphine Sulfate	Lupin Pharmaceuticals,Inc. \| Novel Laboratories, Inc.	2024-02-16	HUMAN PRESCRIPTION DRUG LABEL	7