Home NDC 67457-914 Ultiva
Product NDC 67457-914
11-digit product format 674570914
Labeler code 67457
Product ID 67457-914_4e4a5266-148c-4137-8fed-74766f8c1c7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Remifentanil Hydrochloride
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application NDA020630
Marketing category NDA
Marketing start 2020-04-15
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 RLD / RS Approval date N020630-001 ULTIVA REMIFENTANIL HYDROCHLORIDE EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 N020630-002 ULTIVA REMIFENTANIL HYDROCHLORIDE EQ 2MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 N020630-003 ULTIVA REMIFENTANIL HYDROCHLORIDE EQ 5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-07-12
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 4 · 126 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 2026-08-18 06:07:40 2026-07 N020630-001 ULTIVA EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020630-002 ULTIVA EQ 2MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020630-003 ULTIVA EQ 5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-07-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020630-001 ULTIVA EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020630-002 ULTIVA EQ 2MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020630-003 ULTIVA EQ 5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020630-001 ULTIVA EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020630-002 ULTIVA EQ 2MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020630-003 ULTIVA EQ 5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020630-001 ULTIVA EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020630-002 ULTIVA EQ 2MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020630-003 ULTIVA EQ 5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020630-001 ULTIVA EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020630-002 ULTIVA EQ 2MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020630-003 ULTIVA EQ 5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020630-001 ULTIVA EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020630-002 ULTIVA EQ 2MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020630-003 ULTIVA EQ 5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020630-001 ULTIVA EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020630-002 ULTIVA EQ 2MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020630-003 ULTIVA EQ 5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020630-001 ULTIVA EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020630-002 ULTIVA EQ 2MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020630-003 ULTIVA EQ 5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020630-001 ULTIVA EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020630-002 ULTIVA EQ 2MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020630-003 ULTIVA EQ 5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020630-001 ULTIVA EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020630-002 ULTIVA EQ 2MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020630-003 ULTIVA EQ 5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020630-001 ULTIVA EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020630-002 ULTIVA EQ 2MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020630-003 ULTIVA EQ 5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020630-001 ULTIVA EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020630-002 ULTIVA EQ 2MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020630-003 ULTIVA EQ 5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020630-001 ULTIVA EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020630-002 ULTIVA EQ 2MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020630-003 ULTIVA EQ 5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020630-001 ULTIVA EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ultiva
Listing expiration 2027-12-31 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1729578 Internal RxNorm lookup 1729581 Internal RxNorm lookup 1729584 Internal RxNorm lookup 1729586 Internal RxNorm lookup 1729710 Internal RxNorm lookup 1729712 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 67457-914-00 Ultiva 10 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 10 4 67457-914-05 Ultiva 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 67457-914 ULTIVA (REMIFENTANIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240629_4dbcb8f9-1987-4b66-bd2f-d251fda0be10.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 · 2 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 67457-914-00 67457091400 10 mL in 1 VIAL, GLASS 10 ml Historical 67457-914-05 67457091405 10 VIAL, GLASS in 1 CARTON (67457-914-05) / 10 mL in 1 VIAL, GLASS (67457-914-00) 2020-04-15 0000-00-00 No No Current