Morphine Sulfate

Product NDC: 27808-084
11-digit product format: 278080084
Labeler code: 27808
Product ID: 27808-084_1d7c0b30-da21-4d70-9047-3ad8ac879497
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: SOLUTION
Route: ORAL
Labeler: Tris Pharma Inc
Application: ANDA203518
Marketing category: ANDA
Marketing start: 2015-09-21
Marketing end: 0000-00-00
Substance: MORPHINE SULFATE
Active strength: 10 mg/5mL
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	27808-084		D	Discontinued by firm	2026-08-17
excluded package	package	27808-084	27808-084-01	D	Discontinued by firm	2026-08-17
excluded package	package	27808-084	27808-084-02	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	27808-084-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	27808-084-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	27808-084-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	27808-084-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	27808-084-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	27808-084-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	27808-084-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	27808-084-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	27808-084-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	27808-084-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	27808-084-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	27808-084-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	27808-084-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	27808-084-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	27808-084-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	27808-084-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	27808-084-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	27808-084-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	27808-084-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	27808-084-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	27808-084-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	27808-084-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	27808-084-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	27808-084-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A203518-001	MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL			2015-05-12
A203518-002	MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA		2015-05-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203518-002	AA

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	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2015-05-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203518-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203518-002	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2015-05-12	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A203518-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203518-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203518-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203518-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203518-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203518-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203518-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203518-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203518-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203518-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203518-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203518-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203518-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203518-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203518-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203518-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203518-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203518-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203518-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203518-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203518-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203518-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203518-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203518-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203518-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203518-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203518-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203518-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203518-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203518-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203518-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203518-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203518-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203518-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203518-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203518-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203518-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203518-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203518-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203518-001	AA	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
89941d4c-522d-cee0-b273-43cfa7ef6d35	Product name	4	20250516
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
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
27808-084-01	Morphine Sulfate	1 in 1 CARTON	SOLUTION	1	37
27808-084-01	Morphine Sulfate	100 mL in 1 BOTTLE, UNIT-DOSE	SOLUTION	100	37
27808-084-02	Morphine Sulfate	500 mL in 1 BOTTLE	SOLUTION	500	37

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MORPHINE SULFATE	ACTIVE INGREDIENT	X3P646A2J0	MORPHINE SULFATE SOLUTION [TRIS PHARMA INC]	9
MORPHINE	ACTIVE MOIETY	76I7G6D29C	MORPHINE SULFATE SOLUTION [TRIS PHARMA INC]	9
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	MORPHINE SULFATE SOLUTION [TRIS PHARMA INC]	9
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	MORPHINE SULFATE SOLUTION [TRIS PHARMA INC]	9
EDETATE CALCIUM DISODIUM	INACTIVE INGREDIENT	25IH6R4SGF	MORPHINE SULFATE SOLUTION [TRIS PHARMA INC]	9
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	MORPHINE SULFATE SOLUTION [TRIS PHARMA INC]	9
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	MORPHINE SULFATE SOLUTION [TRIS PHARMA INC]	9
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MORPHINE SULFATE SOLUTION [TRIS PHARMA INC]	9
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	MORPHINE SULFATE SOLUTION [TRIS PHARMA INC]	9
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MORPHINE SULFATE SOLUTION [TRIS PHARMA INC]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	MORPHINE SULFATE SOLUTION [TRIS PHARMA INC]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27808-084	MORPHINE SULFATE SOLUTION [CRANBURY PHARMACEUTICALS, LLC]	35	Legacy NDC, 3 package rows	20250507_d8598654-94ad-4cfb-81d2-9b68e013a428.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 · 5 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	367d508b-3226-42a9-8dc6-f67cdc9979f3	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203518 application number: ANDA203518
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	5422cdac-8073-41fc-8665-ffe9797f5c02	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203518 application number: ANDA203518
Morphine Sulfate	MORPHINE SULFATE	Cranbury Pharmaceuticals, LLC	d8598654-94ad-4cfb-81d2-9b68e013a428	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203518 application number: ANDA203518 ndc (product): 27808-084
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	9bb1fef7-4159-4dca-8a8c-37e53ccc6bab	2024-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203518 application number: ANDA203518
Morphine Sulfate	MORPHINE SULFATE	Bryant Ranch Prepack	b7b86b6d-9a39-494c-bf65-f62e4cdc5807	2023-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203518 application number: ANDA203518

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
892589	morphine sulfate 10 MG in 5 mL Oral Solution	PSN	d8598654-94ad-4cfb-81d2-9b68e013a428	37
892625	morphine sulfate 20 MG in 1 mL Concentrate for Oral Solution	PSN	d8598654-94ad-4cfb-81d2-9b68e013a428	37
892589	morphine sulfate 2 MG/ML Oral Solution	SCD	d8598654-94ad-4cfb-81d2-9b68e013a428	37
892625	morphine sulfate 20 MG/ML Oral Solution	SCD	d8598654-94ad-4cfb-81d2-9b68e013a428	37
892625	morphine sulfate 10 MG per 0.5 ML Concentrate for Oral Solution	SY	d8598654-94ad-4cfb-81d2-9b68e013a428	37
892589	morphine sulfate 10 MG per 5 ML Oral Solution	SY	d8598654-94ad-4cfb-81d2-9b68e013a428	37
892625	morphine sulfate 100 MG per 5 ML Concentrate for Oral Solution	SY	d8598654-94ad-4cfb-81d2-9b68e013a428	37
892625	morphine sulfate 20 MG/ML Concentrate for Oral Solution	SY	d8598654-94ad-4cfb-81d2-9b68e013a428	37
892589	MS 2 MG/ML Oral Solution	SY	d8598654-94ad-4cfb-81d2-9b68e013a428	37
892625	MS 20 MG/ML Oral Solution	SY	d8598654-94ad-4cfb-81d2-9b68e013a428	37

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
27808-084-01	27808008401	1 BOTTLE, UNIT-DOSE in 1 CARTON (27808-084-01) > 100 mL in 1 BOTTLE, UNIT-DOSE		2015-09-21	0000-00-00	No	No	Current
27808-084-02	27808008402	500 mL in 1 BOTTLE (27808-084-02)	500 ml	2015-09-21	0000-00-00	No	No	Current