Morphine Sulfate

Product NDC: 0054-0238
11-digit product format: 000540238
Labeler code: 0054
Product ID: 0054-0238_1bfdbb7c-d06a-4010-82f9-189b59a2f18d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: SOLUTION
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: NDA022195
Marketing category: NDA
Marketing start: 2008-03-17
Substance: MORPHINE SULFATE
Active strength: 20 mg/5mL
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022195-001	MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17
N022195-002	MORPHINE SULFATE	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17
N022195-003	MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N022195-001	AA
N022195-002	AA
N022195-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL		RLD	2008-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-002	MORPHINE SULFATE	20MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-003	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	RLD, RS	2010-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022195-001	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	RLD	2008-03-17	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 122 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	N022195-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022195-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022195-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022195-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022195-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022195-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022195-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022195-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022195-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022195-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022195-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022195-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022195-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022195-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022195-002	AA	1	`8072bd15b7f6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-001	NPP	2024-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022195-002	NPP	2024-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-001	NPP	2024-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022195-002	NPP	2024-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-001	NPP	2024-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022195-002	NPP	2024-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-001	NPP	2024-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022195-002	NPP	2024-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022195-001	NPP	2024-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022195-002	NPP	2024-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-001	NPP	2024-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022195-002	NPP	2024-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-001	NPP	2024-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022195-002	NPP	2024-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-001	NPP	2024-06-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022195-002	NPP	2024-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022195-001	NPP	2024-06-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022195-002	NPP	2024-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022195-001	NPP	2024-06-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022195-002	NPP	2024-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022195-001	NPP	2024-06-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022195-002	NPP	2024-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022195-001	NPP	2024-06-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022195-002	NPP	2024-06-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022195-001	NPP	2024-06-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022195-002	NPP	2024-06-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022195-001	NPP	2024-06-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022195-002	NPP	2024-06-02	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022195-001	NPP	2024-06-02	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022195-002	NPP	2024-06-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022195-001	NPP	2024-06-02	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N022195-002	NPP	2024-06-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022195-001	NPP	2024-06-02	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N022195-002	NPP	2024-06-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022195-001	NPP	2024-06-02	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022195-002	NPP	2024-06-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022195-001	NPP	2024-06-02	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022195-002	NPP	2024-06-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022195-001	NPP	2024-06-02	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022195-002	NPP	2024-06-02	`a67488948f0b…`

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	20 mg/5mL

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
892589	Internal RxNorm lookup
892625	Internal RxNorm lookup
894780	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
ca359246-4674-4b32-b8b2-673d32b7112f	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
67e166c6-23d4-4709-b77d-5ca6182dcae0	Product name	1	20180830
c573a64c-fe17-2eac-fbcb-788868b4ff6b	Product name	9	20180619
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
7a537f54-d322-5e54-a3a2-035d3e21c3c6	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-0238-49	Morphine Sulfate	100 mL in 1 BOTTLE	SOLUTION	100		4
0054-0238-63	Morphine Sulfate	500 mL in 1 BOTTLE	SOLUTION	500		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0238-49	ML - Milliliter	0054-0238	4ce76ead-6101-4f79-8615-798a73979a3c	1	2012-07-24
0054-0238-63	ML - Milliliter	0054-0238	63a84042-2022-4505-9993-b4d89acf299b	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 SOLUTION [ROXANE LABORATORIES, INC]	14
MORPHINE	ACTIVE MOIETY	76I7G6D29C	MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	14
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	14
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	14
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	14
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	14
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	14
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	14
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	14
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	14
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	14
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	14
WATER	INACTIVE INGREDIENT	059QF0KO0R	MORPHINE SULFATE SOLUTION [ROXANE LABORATORIES, INC]	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0238	MORPHINE SULFATE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	2	Current NDC, Legacy NDC, 2 package rows	20231223_ca359246-4674-4b32-b8b2-673d32b7112f.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	6654b91e-3b3f-4062-ac65-a2a70f942da4	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	bb6b3439-9f0c-45f5-bf6f-c7a971af0a8f	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	76966c05-df75-4072-ae99-97e42f91ab75	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	67f0ee8d-696e-4c08-9007-3df0e3988bad	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	Precision Dose Inc.	8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	Hikma Pharmaceuticals USA Inc.	ca359246-4674-4b32-b8b2-673d32b7112f	2026-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195 ndc (product): 0054-0238
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	ae57637e-a86a-4ea5-9c68-47d98153d41a	2026-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	9f1ba2a2-d8ac-4f59-a587-fe413e56dcdb	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	PAI Holdings, LLC dba PAI Pharma	6e32b869-31c7-48c1-98ae-b21bd28151d7	2024-11-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195
Morphine Sulfate	MORPHINE SULFATE	Precision Dose, Inc.	cc50d3c1-b4c8-4edc-9aa0-844d2fed45fb	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022195 application number: NDA022195

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
894780	morphine sulfate 20 MG in 5 mL Oral Solution	PSN	3c6a7216-e49b-411c-b53a-dd952ecfa039	6
894780	morphine sulfate 4 MG/ML Oral Solution	SCD	3c6a7216-e49b-411c-b53a-dd952ecfa039	6
894780	morphine sulfate 20 MG per 5 ML Oral Solution	SY	3c6a7216-e49b-411c-b53a-dd952ecfa039	6
894780	MS 4 MG/ML Oral Solution	SY	3c6a7216-e49b-411c-b53a-dd952ecfa039	6
892589	morphine sulfate 10 MG in 5 mL Oral Solution	PSN	ca359246-4674-4b32-b8b2-673d32b7112f	4
892625	morphine sulfate 20 MG in 1 mL Concentrate for Oral Solution	PSN	ca359246-4674-4b32-b8b2-673d32b7112f	4
894780	morphine sulfate 20 MG in 5 mL Oral Solution	PSN	ca359246-4674-4b32-b8b2-673d32b7112f	4
892589	morphine sulfate 2 MG/ML Oral Solution	SCD	ca359246-4674-4b32-b8b2-673d32b7112f	4
892625	morphine sulfate 20 MG/ML Oral Solution	SCD	ca359246-4674-4b32-b8b2-673d32b7112f	4
894780	morphine sulfate 4 MG/ML Oral Solution	SCD	ca359246-4674-4b32-b8b2-673d32b7112f	4
892625	morphine sulfate 10 MG per 0.5 ML Concentrate for Oral Solution	SY	ca359246-4674-4b32-b8b2-673d32b7112f	4
892589	morphine sulfate 10 MG per 5 ML Oral Solution	SY	ca359246-4674-4b32-b8b2-673d32b7112f	4
892625	morphine sulfate 100 MG per 5 ML Concentrate for Oral Solution	SY	ca359246-4674-4b32-b8b2-673d32b7112f	4
894780	morphine sulfate 20 MG per 5 ML Oral Solution	SY	ca359246-4674-4b32-b8b2-673d32b7112f	4
892625	morphine sulfate 20 MG/ML Concentrate for Oral Solution	SY	ca359246-4674-4b32-b8b2-673d32b7112f	4
892589	MS 2 MG/ML Oral Solution	SY	ca359246-4674-4b32-b8b2-673d32b7112f	4
892625	MS 20 MG/ML Oral Solution	SY	ca359246-4674-4b32-b8b2-673d32b7112f	4
894780	MS 4 MG/ML Oral Solution	SY	ca359246-4674-4b32-b8b2-673d32b7112f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0238-49	00054023849	100 mL in 1 BOTTLE (0054-0238-49)	100 ml	2008-03-17	0000-00-00	No	No	Current
0054-0238-63	00054023863	500 mL in 1 BOTTLE (0054-0238-63)	500 ml	2008-03-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Morphine Sulfate	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2026-02-03	HUMAN PRESCRIPTION DRUG LABEL	4
Morphine Sulfate	ATLANTIC BIOLOGICALS CORP.	2024-05-20	HUMAN PRESCRIPTION DRUG LABEL	6
Morphine Sulfate	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2022-04-18	HUMAN PRESCRIPTION DRUG LABEL	27
Morphine Sulfate	ATLANTIC BIOLOGICALS CORP.	2016-09-09	HUMAN PRESCRIPTION DRUG LABEL	1