Home NDC 0409-9094-28 Fentanyl Citrate
Product NDC 0409-9094
Requested package NDC 0409-9094-28
11-digit product format 004099094
Labeler code 0409
Product ID 0409-9094_8ff8b8cf-1a31-46dc-b350-2b9cc700e6a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FENTANYL CITRATE
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hospira, Inc.
Application NDA019115
Marketing category NDA
Marketing start 2005-09-27
Substance FENTANYL 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 N019115-001 FENTANYL CITRATE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019115-001 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 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019115-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 1985-01-12 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 Fentanyl Citrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FENTANYL 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 MUN5LYG46H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1735003 Internal RxNorm lookup 1735004 Internal RxNorm lookup 1735006 Internal RxNorm lookup 1735007 Internal RxNorm lookup 1735008 Internal RxNorm lookup 1735013 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 0409-9094-12 Fentanyl Citrate 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 34 0409-9094-16 Fentanyl Citrate 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 34 0409-9094-17 Fentanyl Citrate 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 34 0409-9094-18 Fentanyl Citrate 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 34 0409-9094-22 Fentanyl Citrate 25 in 1 TRAY INJECTION, SOLUTION 25 34 0409-9094-25 Fentanyl Citrate 25 in 1 TRAY INJECTION, SOLUTION 25 34 0409-9094-28 Fentanyl Citrate 25 in 1 TRAY INJECTION, SOLUTION 25 34 0409-9094-31 Fentanyl Citrate 25 in 1 TRAY INJECTION, SOLUTION 25 34 0409-9094-41 Fentanyl Citrate 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 50 34 0409-9094-61 Fentanyl Citrate 25 in 1 TRAY INJECTION, SOLUTION 25 34 0409-9094-61 Fentanyl Citrate 1 in 1 CARTON INJECTION, SOLUTION 1 34 0409-9094-09 FENTANYL CITRATE 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 17 0409-9094-11 FENTANYL CITRATE 25 in 1 TRAY INJECTION, SOLUTION 25 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FENTANYL CITRATE ACTIVE INGREDIENT MUN5LYG46H FENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 FENTANYL ACTIVE MOIETY UF599785JZ FENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB FENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I FENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 WATER INACTIVE INGREDIENT 059QF0KO0R FENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-9094 FENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.] 32 Current NDC, Legacy NDC, 11 package rows 20250122_bfa8018a-4cbc-434b-e09e-782872b0340a.zip 0409-9094 FENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.] 16 Current NDC, Legacy NDC, 2 package rows 20241123_1ed25b2c-334e-4021-ada1-3396f07630dc.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 Marketing start Marketing end Sample Exclude flag Status 0409-9094-28 00409909428 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9094-28) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9094-17) 2006-02-17 0000-00-00 No No Current