Home NDC 17478-050 Sufentanil Citrate
Product NDC 17478-050
11-digit product format 174780050
Labeler code 17478
Product ID 17478-050_bcd12213-431a-4210-a668-958ab35a87c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sufentanil Citrate
Dosage form INJECTION
Route EPIDURAL; INTRAVENOUS
Labeler Akorn
Application NDA019050
Marketing category NDA
Marketing start 2010-12-01
Marketing end 0000-00-00
Substance SUFENTANIL CITRATE
Active strength 50 ug/mL
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2023-12-31
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 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019050-001 SUFENTA PRESERVATIVE FREE SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019050-001 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 2 · 43 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 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019050-001 SUFENTA PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-05-04 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 17478-050-01 2024-01-30 C162847 48780-1 1030e365-6562-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use SUFENTANIL CITRATE INJECTION, safely and effectively. See full prescribing information for SUFENTANIL CITRATE INJECTION. Sufentanil Citrate Injection, for intravenous and epidural use, CII Initial U.S. Approval: 1984 17478-050-02 2024-01-30 C162847 48780-1 1030e365-6562-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use SUFENTANIL CITRATE INJECTION, safely and effectively. See full prescribing information for SUFENTANIL CITRATE INJECTION. Sufentanil Citrate Injection, for intravenous and epidural use, CII Initial U.S. Approval: 1984 17478-050-05 2024-01-30 C162847 48780-1 1030e365-6562-111a-e063-dadaa90a10e2 These highlights do not include all the information needed to use SUFENTANIL CITRATE INJECTION, safely and effectively. See full prescribing information for SUFENTANIL CITRATE INJECTION. Sufentanil Citrate Injection, for intravenous and epidural use, CII Initial U.S. Approval: 1984
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17478-050-01 Sufentanil Citrate 1 mL in 1 AMPULE INJECTION 1 9 17478-050-01 Sufentanil Citrate 10 in 1 CARTON INJECTION 10 9 17478-050-02 Sufentanil Citrate 2 mL in 1 AMPULE INJECTION 2 9 17478-050-02 Sufentanil Citrate 10 in 1 CARTON INJECTION 10 9 17478-050-05 Sufentanil Citrate 5 mL in 1 AMPULE INJECTION 5 9 17478-050-05 Sufentanil Citrate 10 in 1 CARTON INJECTION 10 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17478-050 SUFENTANIL CITRATE INJECTION [AKORN] 9 Legacy NDC, 6 package rows 20220919_95e639db-1ca3-4328-b347-7ea348f6cc72.zip
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 17478-050-01 17478005001 10 AMPULE in 1 CARTON (17478-050-01) > 1 mL in 1 AMPULE 10 ampule 2010-12-01 0000-00-00 No No Current 17478-050-02 17478005002 10 AMPULE in 1 CARTON (17478-050-02) > 2 mL in 1 AMPULE 10 ampule 2010-12-01 0000-00-00 No No Current 17478-050-05 17478005005 10 AMPULE in 1 CARTON (17478-050-05) > 5 mL in 1 AMPULE 10 ampule 2010-12-01 0000-00-00 No No Current