Morphine sulfate

Product NDC: 71335-0676
11-digit product format: 713350676
Labeler code: 71335
Product ID: 71335-0676_f5c39af8-abf3-4860-8da0-c1b3ca79e66d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: morphine sulfate
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078761
Marketing category: ANDA
Marketing start: 2012-05-11
Substance: MORPHINE SULFATE
Active strength: 30 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	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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MORPHINE SULFATE	30 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
891888	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
ad08cd86-3825-4e77-bbe8-f6333a9ca9d7	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
71335-0676-0	Morphine sulfate	40 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	40	8
71335-0676-1	Morphine sulfate	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	8
71335-0676-2	Morphine sulfate	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60	8
71335-0676-3	Morphine sulfate	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	8
71335-0676-4	Morphine sulfate	120 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	120	8
71335-0676-5	Morphine sulfate	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	8
71335-0676-6	Morphine sulfate	5 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	5	8
71335-0676-7	Morphine sulfate	15 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	15	8
71335-0676-8	Morphine sulfate	20 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	20	8
71335-0676-9	Morphine sulfate	26 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	26	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0676-1	EA - Each	71335-0676	80f5d187-a986-4351-b488-33619623c0b7	1	2022-02-07
71335-0676-2	EA - Each	71335-0676	2ea866eb-1431-4e28-874a-6f9156e9c97e	1	2022-02-07
71335-0676-3	EA - Each	71335-0676	751fa7df-69b9-4fa2-95f3-5f202713f1b3	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0676	MORPHINE SULFATE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]	8	Current NDC, Legacy NDC, 10 package rows	20240412_ad08cd86-3825-4e77-bbe8-f6333a9ca9d7.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
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 ndc (product): 71335-0676

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
891888	morphine sulfate 30 MG Extended Release Oral Tablet	PSN	ad08cd86-3825-4e77-bbe8-f6333a9ca9d7	8
891888	morphine sulfate 30 MG Extended Release Oral Tablet	SCD	ad08cd86-3825-4e77-bbe8-f6333a9ca9d7	8
891888	MS 30 MG Extended Release Oral Tablet	SY	ad08cd86-3825-4e77-bbe8-f6333a9ca9d7	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0676-0	71335067600	40 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-0)	2024-04-03	0000-00-00	No	No	Current
71335-0676-1	71335067601	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-1)	2018-02-26	0000-00-00	No	No	Current
71335-0676-2	71335067602	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-2)	2018-02-20	0000-00-00	No	No	Current
71335-0676-3	71335067603	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-3)	2018-03-09	0000-00-00	No	No	Current
71335-0676-4	71335067604	120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-4)	2024-04-03	0000-00-00	No	No	Current
71335-0676-5	71335067605	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-5)	2024-04-03	0000-00-00	No	No	Current
71335-0676-6	71335067606	5 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-6)	2024-04-03	0000-00-00	No	No	Current
71335-0676-7	71335067607	15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-7)	2024-04-03	0000-00-00	No	No	Current
71335-0676-8	71335067608	20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-8)	2024-04-03	0000-00-00	No	No	Current
71335-0676-9	71335067609	26 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0676-9)	2024-04-03	0000-00-00	No	No	Current