Application 019115

Type: NDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENTANYL CITRATE	FENTANYL CITRATE	INJECTABLE;INJECTION	EQ 0.05MG BASE/ML	No	No

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…`

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 ndc (product): 0409-9094
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 ndc (product): 0409-9094

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0409-9093	Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	NDA	Current
0409-9093	FENTANYL CITRATE	fentanyl citrate	Hospira, Inc.	NDA	Current
0409-9093	Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	NDA	Current
0409-9093	FENTANYL CITRATE	fentanyl citrate	Hospira, Inc.	NDA	Current
0409-9093	FENTANYL CITRATE	fentanyl citrate	Hospira, Inc.	NDA	Current
0409-9093	Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	NDA	Current
0409-9093	Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	NDA	Current
0409-9093	FENTANYL CITRATE	fentanyl citrate	Hospira, Inc.	NDA	Current
0409-9093	Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	NDA	Current
0409-9093	Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	NDA	Current
0409-9093	FENTANYL CITRATE	fentanyl citrate	Hospira, Inc.	NDA	Current
0409-9093	Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	NDA	Current
0409-9093	FENTANYL CITRATE	fentanyl citrate	Hospira, Inc.	NDA	Current
0409-9093	FENTANYL CITRATE	fentanyl citrate	Hospira, Inc.	NDA	Current
0409-9093	FENTANYL CITRATE	fentanyl citrate	Hospira, Inc.	NDA	Current
0409-9094	Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	NDA	Current
0409-9094	Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	NDA	Current
0409-9094	FENTANYL CITRATE	fentanyl citrate	Hospira, Inc.	NDA	Current
0409-9094	Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	NDA	Current
0409-9094	Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	NDA	Current
0409-9094	FENTANYL CITRATE	fentanyl citrate	Hospira, Inc.	NDA	Current
0409-9094	Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	NDA	Current
0409-9094	Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	NDA	Current
0409-9094	FENTANYL CITRATE	fentanyl citrate	Hospira, Inc.	NDA	Current
0409-9094	Fentanyl Citrate	FENTANYL CITRATE	Hospira, Inc.	NDA	Current
0409-9094	FENTANYL CITRATE	fentanyl citrate	Hospira, Inc.	NDA	Current
0409-9094	FENTANYL CITRATE	fentanyl citrate	Hospira, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84709	SUPPL	2026-01-07
84561	SUPPL	2025-12-29
76990	SUPPL	2023-12-19
76888	SUPPL	2023-12-18
60416	SUPPL	2019-10-09
60270	SUPPL	2019-10-07
46399	SUPPL	2016-12-21
46398	SUPPL	2016-12-21
46229	SUPPL	2016-12-20
46228	SUPPL	2016-12-20