Application 019101

Type: NDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENTANYL CITRATE PRESERVATIVE FREE	FENTANYL CITRATE	INJECTABLE;INJECTION	EQ 0.05MG BASE/ML	Yes	Yes
002	FENTANYL CITRATE	FENTANYL CITRATE	INJECTABLE;INJECTION	EQ 0.025MG BASE/0.5ML	Yes	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019101-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019101-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019101-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019101-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019101-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019101-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019101-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019101-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019101-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019101-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019101-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019101-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019101-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019101-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019101-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019101-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019101-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019101-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019101-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019101-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019101-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019101-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019101-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019101-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019101-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019101-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019101-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019101-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019101-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019101-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019101-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019101-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019101-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019101-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019101-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019101-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019101-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019101-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019101-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019101-001	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 · 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): 0641-6025 ndc (product): 0641-6027 ndc (product): 0641-6024 ndc (product): 0641-6028 ndc (product): 0641-6026 ndc (product): 0641-6030 ndc (product): 0641-6029 ndc (product): 0641-6247
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 ndc (product): 72572-170 ndc (product): 72572-171 ndc (product): 72572-172
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 ndc (product): 81565-205
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-6024	Fentanyl Citrate	Fentanyl Citrate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6024	Fentanyl Citrate	Fentanyl Citrate	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6024	Fentanyl Citrate	Fentanyl Citrate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6025	Fentanyl Citrate	Fentanyl Citrate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6025	Fentanyl Citrate	Fentanyl Citrate	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6025	Fentanyl Citrate	Fentanyl Citrate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6026	Fentanyl Citrate	Fentanyl Citrate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6026	Fentanyl Citrate	Fentanyl Citrate	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6026	Fentanyl Citrate	Fentanyl Citrate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6027	Fentanyl Citrate	Fentanyl Citrate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6027	Fentanyl Citrate	Fentanyl Citrate	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6027	Fentanyl Citrate	Fentanyl Citrate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6028	Fentanyl Citrate	Fentanyl Citrate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6028	Fentanyl Citrate	Fentanyl Citrate	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6028	Fentanyl Citrate	Fentanyl Citrate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6029	Fentanyl Citrate	Fentanyl Citrate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6029	Fentanyl Citrate	Fentanyl Citrate	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6029	Fentanyl Citrate	Fentanyl Citrate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6030	Fentanyl Citrate	Fentanyl Citrate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6030	Fentanyl Citrate	Fentanyl Citrate	West-Ward Pharmaceuticals Corp.	NDA	Current
0641-6030	Fentanyl Citrate	Fentanyl Citrate	Hikma Pharmaceuticals USA Inc.	NDA	Current
0641-6247	Fentanyl Citrate	Fentanyl Citrate	Hikma Pharmaceuticals USA Inc.	NDA	Current
72572-170	Fentanyl Citrate	Fentanyl Citrate	Civica, Inc.	NDA	Current
72572-170	Fentanyl Citrate	Fentanyl Citrate	Civica, Inc.	NDA	Current
72572-171	Fentanyl Citrate	Fentanyl Citrate	Civica, Inc.	NDA	Current
72572-171	Fentanyl Citrate	Fentanyl Citrate	Civica, Inc.	NDA	Current
72572-172	Fentanyl Citrate	Fentanyl Citrate	Civica, Inc.	NDA	Current
81565-205	Fentanyl Citrate	Fentanyl Citrate	Phlow Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84650	SUPPL	2026-01-06
84560	SUPPL	2025-12-29
83537	SUPPL	2025-09-26
83536	SUPPL	2025-09-26
79572	SUPPL	2024-09-10
79571	SUPPL	2024-09-10
76989	SUPPL	2023-12-19
76887	SUPPL	2023-12-18
73944	SUPPL	2023-04-04
73943	SUPPL	2023-04-04
60521	SUPPL	2019-10-10
60415	SUPPL	2019-10-09
57509	SUPPL	2019-02-13
57348	SUPPL	2019-01-25
46400	SUPPL	2016-12-21
46226	SUPPL	2016-12-20