Home NDC 0409-3382-21 Sufentanil Citrate
Product NDC 0409-3382
Requested package NDC 0409-3382-21
11-digit product format 004093382
Labeler code 0409
Product ID 0409-3382_2f400934-519c-4d94-a8d5-bad870eaa1a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SUFENTANIL CITRATE
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA074534
Marketing category ANDA
Marketing start 2005-07-26
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 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074534-001 SUFENTANIL CITRATE SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074534-001 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 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074534-001 SUFENTANIL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1996-12-11 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.
Additional Listing Data#
Finished product Yes
Brand name base Sufentanil Citrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUFENTANIL CITRATE 50 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S9ZFX8403R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1809097 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 0409-3382-11 Sufentanil Citrate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 31 0409-3382-12 Sufentanil Citrate 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 31 0409-3382-15 Sufentanil Citrate 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 31 0409-3382-21 Sufentanil Citrate 10 in 1 CARTON INJECTION, SOLUTION 10 31 0409-3382-22 Sufentanil Citrate 10 in 1 CARTON INJECTION, SOLUTION 10 31 0409-3382-25 Sufentanil Citrate 10 in 1 CARTON INJECTION, SOLUTION 10 31
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SUFENTANIL CITRATE ACTIVE INGREDIENT S9ZFX8403R SUFENTANIL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 SUFENTANIL ACTIVE MOIETY AFE2YW0IIZ SUFENTANIL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB SUFENTANIL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I SUFENTANIL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 WATER INACTIVE INGREDIENT 059QF0KO0R SUFENTANIL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-3382 SUFENTANIL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.] 30 Current NDC, Legacy NDC, 6 package rows 20250109_20293943-46ff-4345-1aa4-929b4e017a25.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0409-3382-21 00409338221 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3382-21) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-3382-11) 2005-07-26 0000-00-00 No No Current