Home NDC 0143-9391 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 43 .
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 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.
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 · 114 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 2026-09-14 22:38:34 2026-08 A210594-001 REMIFENTANIL HYDROCHLORIDE EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP 2020-10-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210594-002 REMIFENTANIL HYDROCHLORIDE EQ 2MG BASE/VIAL INJECTABLE / INJECTION AP 2020-10-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210594-003 REMIFENTANIL HYDROCHLORIDE EQ 5MG BASE/VIAL INJECTABLE / INJECTION AP 2020-10-13 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
DailyMed Product Concepts# 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 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.
DailyMed RxNorm Mappings# 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