Home NDC 0641-6248 Fentanyl Citrate
Product NDC 0641-6248
11-digit product format 006416248
Labeler code 0641
Product ID 0641-6248_546a047c-1faf-4751-9e48-079e4c35b6fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fentanyl Citrate
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application NDA019101
Marketing category NDA
Marketing start 2023-02-01
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019101-001 FENTANYL CITRATE FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 N019101-002 FENTANYL CITRATE FENTANYL CITRATE EQ 0.025MG BASE/0.5ML INJECTABLE / INJECTION RLD, RS 2023-01-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019101-001 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 · 64 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 N019101-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019101-002 FENTANYL CITRATE EQ 0.025MG BASE/0.5ML INJECTABLE / INJECTION RLD, RS 2023-01-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019101-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019101-002 FENTANYL CITRATE EQ 0.025MG BASE/0.5ML INJECTABLE / INJECTION RLD, RS 2023-01-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019101-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019101-002 FENTANYL CITRATE EQ 0.025MG BASE/0.5ML INJECTABLE / INJECTION RLD, RS 2023-01-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019101-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019101-002 FENTANYL CITRATE EQ 0.025MG BASE/0.5ML INJECTABLE / INJECTION RLD, RS 2023-01-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019101-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019101-002 FENTANYL CITRATE EQ 0.025MG BASE/0.5ML INJECTABLE / INJECTION RLD, RS 2023-01-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019101-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019101-002 FENTANYL CITRATE EQ 0.025MG BASE/0.5ML INJECTABLE / INJECTION RLD, RS 2023-01-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019101-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019101-002 FENTANYL CITRATE EQ 0.025MG BASE/0.5ML INJECTABLE / INJECTION RLD, RS 2023-01-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019101-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019101-002 FENTANYL CITRATE EQ 0.025MG BASE/0.5ML INJECTABLE / INJECTION RLD, RS 2023-01-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019101-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019101-002 FENTANYL CITRATE EQ 0.025MG BASE/0.5ML INJECTABLE / INJECTION RLD, RS 2023-01-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019101-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019101-002 FENTANYL CITRATE EQ 0.025MG BASE/0.5ML INJECTABLE / INJECTION RLD, RS 2023-01-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019101-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019101-002 FENTANYL CITRATE EQ 0.025MG BASE/0.5ML INJECTABLE / INJECTION RLD, RS 2023-01-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019101-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019101-002 FENTANYL CITRATE EQ 0.025MG BASE/0.5ML INJECTABLE / INJECTION RLD, RS 2023-01-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019101-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019101-002 FENTANYL CITRATE EQ 0.025MG BASE/0.5ML INJECTABLE / INJECTION RLD, RS 2023-01-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019101-001 FENTANYL CITRATE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019101-002 FENTANYL CITRATE EQ 0.025MG BASE/0.5ML INJECTABLE / INJECTION RLD, RS 2023-01-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019101-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019101-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019101-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019101-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019101-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019101-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019101-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019101-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019101-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019101-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019101-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019101-001 FENTANYL CITRATE PRESERVATIVE FREE EQ 0.05MG BASE/ML INJECTABLE / INJECTION AP RLD, RS 1984-07-11 b00525d2431f…
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 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 · 7 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 2474269 Internal RxNorm lookup 2629337 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 0641-6248-01 Fentanyl Citrate 1 mL in 1 SYRINGE, GLASS INJECTION 1 18 0641-6248-10 Fentanyl Citrate 10 in 1 CARTON INJECTION 10 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6248 FENTANYL CITRATE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 15 Current NDC, 2 package rows 20250402_ce5db1c2-feb1-4ad2-847a-d02e865bd47e.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fentanyl Citrate FENTANYL CITRATE Hikma Pharmaceuticals USA Inc. ce5db1c2-feb1-4ad2-847a-d02e865bd47e 2026-03-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019101 application number: NDA019101 ndc (product): 0641-6248 Fentanyl Citrate FENTANYL CITRATE Civica, Inc. aacf276b-e133-4199-ad3f-67b894744c04 2025-12-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019101 application number: NDA019101 Fentanyl Citrate FENTANYL CITRATE Phlow Corp. 58dcd3f7-e3d8-4929-a186-8f680a51ff11 2025-12-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019101 application number: NDA019101 Fentanyl Citrate FENTANYL CITRATE Hikma Pharmaceuticals USA Inc. c5fcdcbd-1dd1-4ebf-aa0d-edfe845414b7 2025-12-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019101 application number: NDA019101
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0641-6248-01 00641624801 1 mL in 1 SYRINGE, GLASS 1 ml Historical 0641-6248-10 00641624810 10 SYRINGE, GLASS in 1 CARTON (0641-6248-10) / 1 mL in 1 SYRINGE, GLASS (0641-6248-01) 2023-02-01 No No Current