FENTANYL

Product NDC: 63629-4813
11-digit product format: 636294813
Labeler code: 63629
Product ID: 63629-4813_5a1ef461-3ca7-4b4e-8a81-9f2542dcb1a7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FENTANYL
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Bryant Ranch Prepack
Application: ANDA077449
Marketing category: ANDA
Marketing start: 2013-04-04
Marketing end: 2026-01-31
Substance: FENTANYL
Active strength: 100 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-4813		D	Discontinued by firm	2026-10-05
excluded package	package	63629-4813	63629-4813-1	D	Discontinued by firm	2026-10-05
excluded package	package	63629-4813	63629-4813-2	D	Discontinued by firm	2026-10-05
excluded package	package	63629-4813	63629-4813-3	D	Discontinued by firm	2026-10-05

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 · 4 matching rows.

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

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	63629-4813-2
excluded package	package	63629-4813-1
excluded package	package	63629-4813-3

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 344 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
2026-09-14 22:38:34	2026-08	A077449-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077449-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2008-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2015-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2017-12-06	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 304 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077449-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077449-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077449-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077449-008	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4813-1	2020-07-06	These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system, CII Initial U.S. Approval: 1968
63629-4813-2	2020-07-06	These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system, CII Initial U.S. Approval: 1968
63629-4813-3	2020-07-06	These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system, CII Initial U.S. Approval: 1968
63629-4813-1	2020-01-31	These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system, CII Initial U.S. Approval: 1968
63629-4813-2	2020-01-31	These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system, CII Initial U.S. Approval: 1968
63629-4813-3	2020-01-31	These highlights do not include all the information needed to use FENTANYL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for FENTANYL TRANSDERMAL SYSTEM. FENTANYL transdermal system, CII Initial U.S. Approval: 1968

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENTANYL	ACTIVE INGREDIENT	UF599785JZ	FENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1001
FENTANYL	ACTIVE MOIETY	UF599785JZ	FENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1001
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	FENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1001
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	FENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-4813	FENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]	1010	Legacy NDC	20230714_529836fc-527c-45d8-a318-ab5513c053fe.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
63629-4813-1	63629481301	1 h in 1 BOTTLE (63629-4813-1)	1 h	2013-06-10	0000-00-00	No	No	Current
63629-4813-2	63629481302	2 h in 1 BOTTLE (63629-4813-2)	2 h	2013-06-10	0000-00-00	No	No	Current
63629-4813-3	63629481303	5 h in 1 BOTTLE (63629-4813-3)	5 h	2013-06-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FENTANYL - Bryant Ranch Prepack	Bryant Ranch Prepack	2023-07-13	HUMAN PRESCRIPTION DRUG LABEL	1010