Fentanyl Citrate

Product NDC: 81565-205
11-digit product format: 815650205
Labeler code: 81565
Product ID: 81565-205_09e32400-24f3-4cab-9563-30e9f92dc17d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fentanyl Citrate
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Phlow Corp.
Application: NDA019101
Marketing category: NDA
Marketing start: 2023-01-11
Marketing end: 2028-06-30
Substance: FENTANYL CITRATE
Active strength: 50 ug/mL
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
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.

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fentanyl Citrate

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
58dcd3f7-e3d8-4929-a186-8f680a51ff11	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	Strength	SPL version
81565-205-01	Fentanyl Citrate	2 mL in 1 VIAL	INJECTION	2		10
81565-205-02	Fentanyl Citrate	25 in 1 CARTON	INJECTION	25		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81565-205-01	ML - Milliliter	81565-205	874cd3e8-fedf-47cb-9448-6b818b56ba45	1	2023-06-06
81565-205-02	ML - Milliliter	81565-205	0ad1b6e5-5e9c-43c1-948e-fac6c8357b21	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81565-205	FENTANYL CITRATE INJECTION [PHLOW CORP.]	5	Current NDC, Legacy NDC, 2 package rows	20240614_58dcd3f7-e3d8-4929-a186-8f680a51ff11.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
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 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

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	58dcd3f7-e3d8-4929-a186-8f680a51ff11	10
1735003	2 ML fentanyl 0.05 MG/ML Injection	SCD	58dcd3f7-e3d8-4929-a186-8f680a51ff11	10
1735003	fentanyl (as fentanyl citrate) 50 MCG/ML per 2 ML Injection	SY	58dcd3f7-e3d8-4929-a186-8f680a51ff11	10
1735003	fentanyl citrate 100 MCG per 2 ML Injection	SY	58dcd3f7-e3d8-4929-a186-8f680a51ff11	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81565-205-01	81565020501	2 mL in 1 VIAL	2 ml					Historical
81565-205-02	81565020502	25 VIAL in 1 CARTON (81565-205-02) / 2 mL in 1 VIAL (81565-205-01)	25 vial	2023-01-11	2028-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fentanyl Citrate	Phlow Corp. \| Hikma Pharmaceuticals USA Inc.	2025-12-23	HUMAN PRESCRIPTION DRUG LABEL	10