Home NDC 63323-817-20 Fentanyl Citrate
Product NDC 63323-817
Requested package NDC 63323-817-20
11-digit product format 633230817
Labeler code 63323
Product ID 63323-817_8fca5c17-40f0-4b06-8beb-fd2f49229f7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fentanyl Citrate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA212086
Marketing category ANDA
Marketing start 2021-01-15
Marketing end 0000-00-00
Substance FENTANYL CITRATE
Active strength 100 ug/2mL
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 · 12 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…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A212086-001 FENTANYL CITRATE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212086-001 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.
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 2026-08-18 06:07:40 2026-07 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION 2020-09-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212086-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP 2020-09-01 a50c72e98297…
Observed Orange Book normalized TE history# 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 Units Marketing start Marketing end Sample Exclude flag Status 63323-817-20 63323081720 10 SYRINGE in 1 CARTON (63323-817-20) > 2 mL in 1 SYRINGE (63323-817-01) 10 syringe 2021-01-15 0000-00-00 No No Current