FENTANYL

Product NDC: 60505-7010
11-digit product format: 605057010
Labeler code: 60505
Product ID: 60505-7010_3667df05-f059-309d-c2e7-1b1be5c9388e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FENTANYL
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Apotex Corp.
Application: ANDA077449
Marketing category: ANDA
Marketing start: 2016-01-22
Marketing end: 2026-02-28
Substance: FENTANYL
Active strength: 12 ug/h
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60505-7010		D	Discontinued by firm		2026-08-07
excluded package	package	60505-7010	60505-7010-2	D	Discontinued by firm		2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077449-001	FENTANYL-25	FENTANYL	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20
A077449-002	FENTANYL-50	FENTANYL	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20
A077449-003	FENTANYL-75	FENTANYL	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20
A077449-004	FENTANYL-100	FENTANYL	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20
A077449-005	FENTANYL-12	FENTANYL	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-09-11
A077449-006	FENTANYL-37	FENTANYL	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06
A077449-007	FENTANYL-62	FENTANYL	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06
A077449-008	FENTANYL-87	FENTANYL	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A077449-001	AB
A077449-002	AB
A077449-003	AB
A077449-004	AB
A077449-005	AB
A077449-006	AB
A077449-007	AB
A077449-008	AB

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 9 · 328 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	A077449-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077449-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077449-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077449-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077449-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077449-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077449-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077449-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077449-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077449-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077449-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077449-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077449-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077449-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077449-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077449-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077449-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077449-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 288 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	A077449-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077449-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077449-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077449-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077449-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077449-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077449-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077449-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077449-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077449-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077449-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077449-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077449-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077449-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077449-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077449-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077449-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077449-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077449-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077449-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077449-008	AB	1	`b8a1b40f171c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-7010-0	EA - Each	60505-7010	3c962bd6-fc29-46ea-900e-788b49bffc36	1	2016-02-04
60505-7010-2	EA - Each	60505-7010	7416929e-a463-4d2b-a671-38925b1ba1c5	1	2016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENTANYL	ACTIVE INGREDIENT	UF599785JZ	FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]	5
FENTANYL	ACTIVE MOIETY	UF599785JZ	FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]	5
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]	5
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]	5
POLYBUTENE (1400 MW)	INACTIVE INGREDIENT	1NA5AO9GH7	FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]	5
POLYISOBUTYLENE (800000 MW)	INACTIVE INGREDIENT	Y132ZOQ9H7	FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-7010	FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]	17	Legacy NDC	20230714_0ff70df0-2cda-d96c-42a8-3bf180310498.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	FENTANYL	Aveva Drug Delivery Systems Inc.	73897c38-e4ec-40bc-9f41-3359ee23a5a8	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077449 application number: ANDA077449
FENTANYL	FENTANYL	INGENUS PHARMACEUTICALS, LLC	bf02ffd0-cc5d-446b-b648-378f6885052f	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077449 application number: ANDA077449

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UF599785JZ	FENTANYL	437-38-7	FENTANYL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-7010-2	60505701002	5 POUCH in 1 CARTON (60505-7010-2) > 1 PATCH in 1 POUCH (60505-7010-0) > 72 h in 1 PATCH	5 pouch	2016-01-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FENTANYL - Apotex Corp. \| Aveva Drug Delivery Systems Inc.	Apotex Corp. \| Aveva Drug Delivery Systems Inc.	2023-07-13	HUMAN PRESCRIPTION DRUG LABEL	17
FENTANYL - Bryant Ranch Prepack	Bryant Ranch Prepack	2021-12-27	HUMAN PRESCRIPTION DRUG LABEL	7