Morphine Sulfate

Product NDC: 0121-4955
11-digit product format: 001214955
Labeler code: 0121
Product ID: 0121-4955_8a1bb0fe-ab24-4c30-b843-d06c61fcf0cb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: MORPHINE SULFATE
Dosage form: SOLUTION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: ANDA206573
Marketing category: ANDA
Marketing start: 2025-09-15
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: 2027-12-31
Current FDA listing: Yes

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
A206573-001	MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA		2016-11-14
A206573-002	MORPHINE SULFATE	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA		2023-09-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A206573-001	AA
A206573-002	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 2 · 63 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	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206573-002	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2023-09-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206573-002	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2023-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206573-002	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2023-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206573-002	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2023-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL		2016-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206573-002	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2023-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL		2016-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206573-002	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2023-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL		2016-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206573-002	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2023-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL		2016-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206573-002	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2023-09-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL		2016-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206573-002	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2023-09-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL		2016-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206573-002	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2023-09-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL		2016-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206573-002	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL		2023-09-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206573-002	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2023-09-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206573-002	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2023-09-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206573-002	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2023-09-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206573-002	MORPHINE SULFATE	10MG/5ML	SOLUTION / ORAL	AA	2023-09-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206573-001	MORPHINE SULFATE	100MG/5ML	SOLUTION / ORAL	AA	2016-11-14	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 49 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	A206573-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206573-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206573-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206573-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206573-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206573-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206573-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206573-002	AA	1	`6a471c1ec25d…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206573-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206573-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206573-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206573-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206573-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206573-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206573-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206573-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206573-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206573-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206573-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206573-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206573-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206573-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206573-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206573-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206573-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206573-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206573-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206573-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206573-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206573-001	AA	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206573-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206573-001	AA	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A206573-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206573-001	AA	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A206573-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206573-001	AA	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206573-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206573-001	AA	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206573-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206573-001	AA	1	`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	10 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
892589	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
9405556c-20e0-4e47-b1b0-7872bcc6517e	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
0121-4955-05	Morphine Sulfate	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	21
0121-4955-94	Morphine Sulfate	10 in 1 TRAY	SOLUTION	10	21
0121-4955-94	Morphine Sulfate	3 in 1 CASE	SOLUTION	3	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-4955-05	ML - Milliliter	0121-4955	e4eb7b85-2cd8-4334-b134-e17a8f2cd3fe	1	2025-10-14
0121-4955-94	ML - Milliliter	0121-4955	62e80bbd-fb6c-4fd3-a975-60ef0c3851b3	1	2025-10-14

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Morphine Sulfate	MORPHINE SULFATE	American Health Packaging	66a3f607-7f48-490f-84dd-b74dd1ee39e5	2026-02-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206573 application number: ANDA206573
Morphine Sulfate	MORPHINE SULFATE	PAI Holdings, LLC dba PAI Pharma	9405556c-20e0-4e47-b1b0-7872bcc6517e	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206573 application number: ANDA206573 ndc (product): 0121-4955

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	9405556c-20e0-4e47-b1b0-7872bcc6517e	21
892589	morphine sulfate 2 MG/ML Oral Solution	SCD	9405556c-20e0-4e47-b1b0-7872bcc6517e	21
892589	morphine sulfate 10 MG per 5 ML Oral Solution	SY	9405556c-20e0-4e47-b1b0-7872bcc6517e	21
892589	MS 2 MG/ML Oral Solution	SY	9405556c-20e0-4e47-b1b0-7872bcc6517e	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0121-4955-05	00121495505	5 mL in 1 CUP, UNIT-DOSE	5 ml				Historical
0121-4955-94	00121495594	3 TRAY in 1 CASE (0121-4955-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4955-05)	3 tray	2025-09-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Morphine Sulfate	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2026-01-13	HUMAN PRESCRIPTION DRUG LABEL	21