Home NDC 63323-806 Fentanyl Citrate
Product NDC 63323-806
11-digit product format 633230806
Labeler code 63323
Product ID 63323-806_341b092a-1f6f-40f1-98f2-9346bf2e1242
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fentanyl Citrate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA210762
Marketing category ANDA
Marketing start 2019-05-03
Substance FENTANYL CITRATE
Active strength .05 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 1 .
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 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210762-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210762-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2019-05-03 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Fentanyl Citrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FENTANYL CITRATE .05 mg/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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1735003 Internal RxNorm lookup 1735007 Internal RxNorm lookup 1735008 Internal RxNorm lookup 1735013 Internal RxNorm lookup 2168270 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 63323-806-01 Fentanyl Citrate 25 in 1 CARTON INJECTION, SOLUTION 25 10 63323-806-02 Fentanyl Citrate 25 in 1 CARTON INJECTION, SOLUTION 25 10 63323-806-05 Fentanyl Citrate 25 in 1 CARTON INJECTION, SOLUTION 25 10 63323-806-11 Fentanyl Citrate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 10 63323-806-12 Fentanyl Citrate 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 10 63323-806-13 Fentanyl Citrate 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 10 63323-806-14 Fentanyl Citrate 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 10 63323-806-20 Fentanyl Citrate 25 in 1 CARTON INJECTION, SOLUTION 25 10 63323-806-50 Fentanyl Citrate 1 in 1 CARTON INJECTION, SOLUTION 1 10 63323-806-50 Fentanyl Citrate 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 50 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-806 FENTANYL CITRATE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 10 Current NDC, Legacy NDC, 10 package rows 20250202_38d0c14a-a0c1-44cc-a939-0304eb8037d6.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.
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 63323-806-01 63323080601 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-806-11) 2019-05-03 0000-00-00 No No Current 63323-806-02 63323080602 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-806-12) 2019-05-03 0000-00-00 No No Current 63323-806-05 63323080605 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-806-13) 2019-05-03 0000-00-00 No No Current 63323-806-11 63323080611 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 63323-806-12 63323080612 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical 63323-806-13 63323080613 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical 63323-806-14 63323080614 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 63323-806-20 63323080620 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-806-14) 2019-05-03 0000-00-00 No No Current 63323-806-50 63323080650 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-806-50) / 50 mL in 1 VIAL, SINGLE-DOSE 2019-05-03 0000-00-00 No No Current