FENTANYL CITRATE

Product NDC: 0409-9093
11-digit product format: 004099093
Labeler code: 0409
Product ID: 0409-9093_5c5d5060-ba53-4e88-b390-f03217605d11
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: 2016-12-06
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0409-9093		D	Discontinued by firm	2026-08-07
excluded package	package	0409-9093	0409-9093-36	D	Discontinued by firm	2026-08-07
excluded package	package	0409-9093	0409-9093-38	D	Discontinued by firm	2026-08-07

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 · 51 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0409-9093-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0409-9093-35	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0409-9093-36	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0409-9093-38	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0409-9093-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0409-9093-35	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0409-9093-36	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0409-9093-38	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0409-9093-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0409-9093-35	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0409-9093-36	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0409-9093-38	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0409-9093-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0409-9093-35	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0409-9093-36	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0409-9093-38	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0409-9093-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0409-9093-35	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0409-9093-36	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0409-9093-38	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0409-9093-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0409-9093-35	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0409-9093-36	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0409-9093-38	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0409-9093-32	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0409-9093-35	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0409-9093-36	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0409-9093-38	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0409-9093-35	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0409-9093-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0409-9093-38	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0409-9093-36	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0409-9093-35	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0409-9093-32	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0409-9093-38	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0409-9093-36	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0409-9093-38	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0409-9093-36	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0409-9093-38	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0409-9093-36	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0409-9093-38	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0409-9093-36	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	N019115-001	FENTANYL CITRATE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	1985-01-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019115-001	FENTANYL CITRATE	EQ 0.05MG BASE/ML	INJECTABLE / INJECTION	AP	1985-01-12	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019115-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019115-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019115-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019115-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019115-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019115-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019115-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019115-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019115-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019115-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019115-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019115-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019115-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019115-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019115-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019115-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019115-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019115-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019115-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019115-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019115-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019115-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019115-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019115-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019115-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019115-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019115-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019115-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019115-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019115-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019115-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019115-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019115-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019115-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019115-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019115-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019115-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019115-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019115-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019115-001	AP	1	`cb3db0bc1861…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1735003	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1ed25b2c-334e-4021-ada1-3396f07630dc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
77d14d2b-b9bf-4254-8dd6-c60dedb281d3	Product name	1	20231002
a8df478d-5b88-9654-981b-87dff14dda8b	Product name	2	20190801
e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57	Product name	2	20180118
bb365072-425e-ca0a-021e-fd8b78162502	Product name	2	20161228
339915c8-cc8f-ceb4-1d3f-5ea267d21ea6	Product name	2	20160104
739fa0ac-b690-63c4-9904-e20dffbf78f9	Product name	1	20140508
7763fcbb-367d-ed06-b37f-e1529b6241be	Product name	1	20140508
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0409-9093-31	Fentanyl Citrate	20 mL in 1 AMPULE	INJECTION, SOLUTION	20	34
0409-9093-36	Fentanyl Citrate	5 in 1 CARTON	INJECTION, SOLUTION	5	34
0409-9093-38	Fentanyl Citrate	5 in 1 CARTON	INJECTION, SOLUTION	5	34
0409-9093-41	Fentanyl Citrate	10 mL in 1 AMPULE	INJECTION, SOLUTION	10	34
0409-9093-09	FENTANYL CITRATE	2 mL in 1 AMPULE	INJECTION, SOLUTION	2	17
0409-9093-11	FENTANYL CITRATE	10 in 1 CELLO PACK	INJECTION, SOLUTION	10	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-9093-09	ML - Milliliter	0409-9093	8c8321a0-3a3e-493a-b63a-11f80fd01a48	1	2017-07-07
0409-9093-11	ML - Milliliter	0409-9093	16546039-6629-4e19-b1b6-43e72476ac00	1	2016-10-06
0409-9093-31	ML - Milliliter	0409-9093	1b9f421f-17ca-4cb3-a035-7adf8613d85e	1	2016-11-08
0409-9093-32	ML - Milliliter	0409-9093	62ea0a31-4874-41d0-a37c-3b0d397dc936	1	2012-07-24
0409-9093-35	ML - Milliliter	0409-9093	2af7c812-df49-48a5-a0f8-973fcf8b4342	1	2012-07-24
0409-9093-36	ML - Milliliter	0409-9093	01bdba66-d141-4125-a15d-9015f35b45af	1	2012-07-24
0409-9093-37	ML - Milliliter	0409-9093	414272bc-a96d-4c75-9cd3-b9c3b60e915e	1	2017-06-15
0409-9093-38	ML - Milliliter	0409-9093	92ad221b-5202-48d1-9a0d-c632d6f491f7	1	2012-07-24
0409-9093-45	ML - Milliliter	0409-9093	4338066a-618f-4375-bfd2-d3954f67eb14	1	2017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
0409-9093	FENTANYL CITRATE INJECTION, SOLUTION [HOSPIRA, INC.]	32	Current NDC, Legacy NDC, 4 package rows	20250122_bfa8018a-4cbc-434b-e09e-782872b0340a.zip
0409-9093	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENTANYL CITRATE	FENTANYL CITRATE	Hospira, Inc.	1ed25b2c-334e-4021-ada1-3396f07630dc	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019115 application number: NDA019115 ndc (product): 0409-9093
Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	bfa8018a-4cbc-434b-e09e-782872b0340a	2026-02-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019115 application number: NDA019115 ndc (product): 0409-9093

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MUN5LYG46H	FENTANYL CITRATE	990-73-8	FENTANYL CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1735003	fentaNYL citrate 100 MCG in 2 ML Injection	PSN	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735008	fentaNYL citrate 1000 MCG in 20 ML Injection	PSN	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735007	fentaNYL citrate 250 MCG in 5 ML Injection	PSN	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735013	fentaNYL citrate 2500 MCG in 50 ML Injection	PSN	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735006	fentaNYL citrate 500 MCG in 10 ML Injection	PSN	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735006	10 ML fentanyl 0.05 MG/ML Injection	SCD	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735003	2 ML fentanyl 0.05 MG/ML Injection	SCD	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735008	20 ML fentanyl 0.05 MG/ML Injection	SCD	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735007	5 ML fentanyl 0.05 MG/ML Injection	SCD	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735013	50 ML fentanyl 0.05 MG/ML Injection	SCD	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735004	fentanyl 0.05 MG/ML Injection	SCD	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735004	fentanyl (as fentanyl citrate) 0.05 MG/ML Injection	SY	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735006	fentanyl (as fentanyl citrate) 50 MCG/ML per 10 ML Injection	SY	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735003	fentanyl (as fentanyl citrate) 50 MCG/ML per 2 ML Injection	SY	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735008	fentanyl (as fentanyl citrate) 50 MCG/ML per 20 ML Injection	SY	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735007	fentanyl (as fentanyl citrate) 50 MCG/ML per 5 ML Injection	SY	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735013	fentanyl (as fentanyl citrate) 50 MCG/ML per 50 ML Injection	SY	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735003	fentanyl citrate 100 MCG per 2 ML Injection	SY	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735008	fentanyl citrate 1000 MCG per 20 ML Injection	SY	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735007	fentanyl citrate 250 MCG per 5 ML Injection	SY	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735013	fentanyl citrate 2500 MCG per 50 ML Injection	SY	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735006	fentanyl citrate 500 MCG per 10 ML Injection	SY	bfa8018a-4cbc-434b-e09e-782872b0340a	34
1735003	fentaNYL citrate 100 MCG in 2 ML Injection	PSN	1ed25b2c-334e-4021-ada1-3396f07630dc	17
1735003	2 ML fentanyl 0.05 MG/ML Injection	SCD	1ed25b2c-334e-4021-ada1-3396f07630dc	17
1735003	fentanyl (as fentanyl citrate) 50 MCG/ML per 2 ML Injection	SY	1ed25b2c-334e-4021-ada1-3396f07630dc	17
1735003	fentanyl citrate 100 MCG per 2 ML Injection	SY	1ed25b2c-334e-4021-ada1-3396f07630dc	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-9093-09	00409909309	2 mL in 1 AMPULE	2 ml					Historical
0409-9093-11	00409909311	10 AMPULE in 1 CELLO PACK (0409-9093-11) / 2 mL in 1 AMPULE (0409-9093-09)	10 ampule	2016-12-06	0000-00-00	No	No	Current
0409-9093-31	00409909331	20 mL in 1 AMPULE	20 ml					Historical
0409-9093-32	00409909332	10 AMPULE in 1 CELLO PACK (0409-9093-32) > 2 mL in 1 AMPULE (0409-9093-37)	10 ampule	2005-11-15	0000-00-00	No	No	Current
0409-9093-35	00409909335	10 AMPULE in 1 CELLO PACK (0409-9093-35) > 5 mL in 1 AMPULE (0409-9093-45)	10 ampule	2005-12-14	0000-00-00	No	No	Current
0409-9093-36	00409909336	5 in 1 CARTON						Historical
0409-9093-38	00409909338	5 in 1 CARTON						Historical
0409-9093-41	00409909341	10 mL in 1 AMPULE	10 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FENTANYL CITRATE	Hospira, Inc.	2026-04-07	HUMAN PRESCRIPTION DRUG LABEL	17
Fentanyl Citrate	Hospira, Inc.	2026-02-25	HUMAN PRESCRIPTION DRUG LABEL	34