MITIGO

Product NDC: 66794-162
11-digit product format: 667940162
Labeler code: 66794
Product ID: 66794-162_495a6a51-d35d-2b96-e063-6394a90ac5f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Morphine Sulfate
Dosage form: INJECTION
Route: EPIDURAL; INTRATHECAL
Labeler: Piramal Critical Care, Inc.
Application: ANDA204393
Marketing category: ANDA
Marketing start: 2018-10-15
Substance: MORPHINE SULFATE
Active strength: 500 mg/20mL
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
A204393-001	MITIGO	MORPHINE SULFATE	10MG/ML	INJECTABLE / INJECTION	AP		2018-07-16
A204393-002	MITIGO	MORPHINE SULFATE	25MG/ML	INJECTABLE / INJECTION	AP		2018-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204393-001	AP
A204393-002	AP

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	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204393-001	MITIGO	10MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204393-002	MITIGO	25MG/ML	INJECTABLE / INJECTION	AP	2018-07-16	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A204393-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204393-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204393-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204393-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204393-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204393-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204393-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204393-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204393-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204393-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204393-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204393-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204393-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204393-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204393-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204393-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204393-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204393-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204393-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204393-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204393-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204393-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204393-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204393-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204393-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204393-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204393-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204393-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204393-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204393-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204393-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204393-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204393-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204393-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204393-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204393-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204393-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204393-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204393-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204393-002	AP	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: MITIGO
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MORPHINE SULFATE	500 mg/20mL

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1731522	Internal RxNorm lookup
1731998	Internal RxNorm lookup
2055307	Internal RxNorm lookup
2055311	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
728f3d83-9a63-0c1f-e053-2a91aa0ac7db	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	Strength	SPL version
66794-162-02	MITIGO	1 mL in 1 VIAL, SINGLE-USE	INJECTION	1		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66794-162-02	ML - Milliliter	66794-162	05b7fe0d-3f22-468d-83a0-b02e656c15cf	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66794-162	MITIGO (MORPHINE SULFATE) INJECTION [PIRAMAL CRITICAL CARE, INC.]	16	Current NDC, Legacy NDC, 1 package rows	20240926_728f3d83-9a63-0c1f-e053-2a91aa0ac7db.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
MITIGO	MORPHINE SULFATE	Piramal Critical Care, Inc.	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	2026-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204393 application number: ANDA204393 ndc (product): 66794-162

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
2055307	MITIGO 200 MG in 20 ML Injection	PSN	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
2055311	MITIGO 500 MG in 20 ML Injection	PSN	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
1731998	morphine sulfate 200 MG in 20 ML Injection	PSN	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
1731522	morphine sulfate 500 MG in 20 ML Injection	PSN	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
2055307	20 ML morphine sulfate 10 MG/ML Injection [Mitigo]	SBD	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
2055311	20 ML morphine sulfate 25 MG/ML Injection [Mitigo]	SBD	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
1731998	20 ML morphine sulfate 10 MG/ML Injection	SCD	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
1731522	20 ML morphine sulfate 25 MG/ML Injection	SCD	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
2055307	20 ML Mitigo 10 MG/ML Injection	SY	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
2055311	20 ML Mitigo 25 MG/ML Injection	SY	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
1731998	20 ML MS 10 MG/ML Injection	SY	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
2055307	20 ML MS 10 MG/ML Injection [Mitigo]	SY	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
1731522	20 ML MS 25 MG/ML Injection	SY	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
2055311	20 ML MS 25 MG/ML Injection [Mitigo]	SY	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
2055307	Mitigo 200 MG per 20 ML Injection	SY	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
2055311	Mitigo 500 MG per 20 ML Injection	SY	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
1731998	morphine sulfate 200 MG per 20 ML Injection	SY	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19
1731522	morphine sulfate 500 MG per 20 ML Injection	SY	728f3d83-9a63-0c1f-e053-2a91aa0ac7db	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66794-162-02	66794016202	1 mL in 1 VIAL, SINGLE-USE (66794-162-02)	1 ml	2018-10-15	0000-00-00	No	No	Current