REMIFENTANIL HYDROCHLORIDE

Product NDC: 0143-9391
11-digit product format: 001439391
Labeler code: 0143
Product ID: 0143-9391_5c5e498b-d829-4f78-bcca-466631014767
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: REMIFENTANIL HYDROCHLORIDE
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA210594
Marketing category: ANDA
Marketing start: 2021-05-15
Substance: REMIFENTANIL HYDROCHLORIDE
Active strength: 1 mg/mL
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 42.

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	Approval date
A210594-001	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13
A210594-002	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13
A210594-003	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210594-001	AP
A210594-002	AP
A210594-003	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 · 111 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	A210594-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210594-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210594-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210594-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210594-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210594-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210594-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210594-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210594-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210594-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210594-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210594-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210594-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210594-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210594-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210594-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210594-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210594-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210594-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210594-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210594-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210594-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210594-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210594-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210594-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210594-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210594-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210594-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210594-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210594-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210594-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210594-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210594-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210594-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210594-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210594-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210594-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210594-002	REMIFENTANIL HYDROCHLORIDE	EQ 2MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210594-003	REMIFENTANIL HYDROCHLORIDE	EQ 5MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210594-001	REMIFENTANIL HYDROCHLORIDE	EQ 1MG BASE/VIAL	INJECTABLE / INJECTION	AP	2020-10-13	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A210594-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210594-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210594-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210594-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210594-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210594-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210594-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210594-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210594-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210594-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210594-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210594-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210594-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210594-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210594-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210594-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210594-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210594-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210594-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210594-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210594-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210594-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210594-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210594-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210594-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210594-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210594-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210594-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210594-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210594-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210594-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210594-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210594-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210594-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210594-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210594-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210594-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210594-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210594-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210594-001	AP	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: REMIFENTANIL HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
REMIFENTANIL HYDROCHLORIDE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5V444H5WIC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1729578	Internal RxNorm lookup
1729584	Internal RxNorm lookup
1729710	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
9d289052-1eb6-4ba2-a3ca-d2e542a052ae	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
672afe0b-f5cc-4f09-b505-57eb5a9ce437	Product name	2	20210513
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9391-01	REMIFENTANIL HYDROCHLORIDE	3 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	3		4
0143-9391-10	REMIFENTANIL HYDROCHLORIDE	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9391-01	EA - Each	0143-9391	41375f20-99e9-4a4e-8a08-f8641e5985a4	1	2021-12-08
0143-9391-10	EA - Each	0143-9391	e63560b1-c5c2-4c76-a288-5b4fb778beef	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9391	REMIFENTANIL HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240312_9d289052-1eb6-4ba2-a3ca-d2e542a052ae.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
REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	9d289052-1eb6-4ba2-a3ca-d2e542a052ae	2024-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210594 application number: ANDA210594 ndc (product): 0143-9391

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5V444H5WIC	REMIFENTANIL HYDROCHLORIDE	132539-07-2	REMIFENTANIL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1729578	remifentanil 1 MG Injection	PSN	9d289052-1eb6-4ba2-a3ca-d2e542a052ae	4
1729584	remifentanil 2 MG Injection	PSN	9d289052-1eb6-4ba2-a3ca-d2e542a052ae	4
1729710	remifentanil 5 MG Injection	PSN	9d289052-1eb6-4ba2-a3ca-d2e542a052ae	4
1729578	remifentanil 1 MG Injection	SCD	9d289052-1eb6-4ba2-a3ca-d2e542a052ae	4
1729584	remifentanil 2 MG Injection	SCD	9d289052-1eb6-4ba2-a3ca-d2e542a052ae	4
1729710	remifentanil 5 MG Injection	SCD	9d289052-1eb6-4ba2-a3ca-d2e542a052ae	4
1729578	remifentanil (as remifentanil hydrochloride) 1 MG Injection	SY	9d289052-1eb6-4ba2-a3ca-d2e542a052ae	4
1729584	remifentanil (as remifentanil hydrochloride) 2 MG Injection	SY	9d289052-1eb6-4ba2-a3ca-d2e542a052ae	4
1729710	remifentanil (as remifentanil hydrochloride) 5 MG Injection	SY	9d289052-1eb6-4ba2-a3ca-d2e542a052ae	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9391-01	00143939101	3 mL in 1 VIAL	3 ml					Historical
0143-9391-10	00143939110	10 VIAL in 1 CARTON (0143-9391-10) / 3 mL in 1 VIAL (0143-9391-01)	10 vial	2021-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
REMIFENTANIL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc. \| Hospira, Inc. \| Navinta LLC	2024-01-01	HUMAN PRESCRIPTION DRUG LABEL	4