Home NDC 67457-198-03 Ultiva
Product NDC 67457-198
Requested package NDC 67457-198-03
11-digit product format 674570198
Labeler code 67457
Product ID 67457-198_6daaa2d2-b002-40d3-8a4b-59a460b46053
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 1996-11-06
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…
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 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 · 129 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 N020630-001 ULTIVA EQ 1MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020630-002 ULTIVA EQ 2MG BASE/VIAL INJECTABLE / INJECTION AP RLD 1996-07-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020630-003 ULTIVA EQ 5MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS 1996-07-12 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Remifentanil Hydrochloride ACTIVE INGREDIENT 5V444H5WIC ULTIVA (REMIFENTANIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 5 Remifentanil ACTIVE MOIETY P10582JYYK ULTIVA (REMIFENTANIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 5 Glycine INACTIVE INGREDIENT TE7660XO1C ULTIVA (REMIFENTANIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 5 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB ULTIVA (REMIFENTANIL HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 5
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67457-198-03 67457019803 10 VIAL, GLASS in 1 CARTON (67457-198-03) > 3 mL in 1 VIAL, GLASS (67457-198-00) 1996-11-06 0000-00-00 No No Current