FENTANYL

Product NDC: 0378-9123
11-digit product format: 003789123
Labeler code: 0378
Product ID: 0378-9123_a6e21c86-57e5-4be5-b1bb-c894893991b2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FENTANYL
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA076258
Marketing category: ANDA
Marketing start: 2005-01-31
Substance: FENTANYL
Active strength: 75 ug/h
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A076258-001	FENTANYL-25	FENTANYL	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28
A076258-002	FENTANYL-50	FENTANYL	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28
A076258-003	FENTANYL-75	FENTANYL	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28
A076258-004	FENTANYL-100	FENTANYL	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28
A076258-005	FENTANYL-12	FENTANYL	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2007-01-23
A076258-006	FENTANYL-37	FENTANYL	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29
A076258-007	FENTANYL-62	FENTANYL	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29
A076258-008	FENTANYL-87	FENTANYL	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076258-001	AB
A076258-002	AB
A076258-003	AB
A076258-004	AB
A076258-005	AB
A076258-006	AB
A076258-007	AB
A076258-008	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	A076258-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2007-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2007-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076258-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2007-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2007-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-001	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-002	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-003	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-004	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2005-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-005	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2007-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-006	FENTANYL-37	37.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-007	FENTANYL-62	62.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-008	FENTANYL-87	87.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2014-12-29	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 317 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	A076258-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076258-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076258-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076258-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076258-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076258-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076258-008	AB	1	`b8a1b40f171c…`

Additional Listing Data#

Finished product: Yes
Brand name base: FENTANYL
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FENTANYL	75 ug/h

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
UF599785JZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197696	Internal RxNorm lookup
245134	Internal RxNorm lookup
245135	Internal RxNorm lookup
245136	Internal RxNorm lookup
577057	Internal RxNorm lookup
1603495	Internal RxNorm lookup
1603498	Internal RxNorm lookup
1603501	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
2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	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	SPL version
0378-9123-16	FENTANYL	1 in 1 POUCH	PATCH	1	27
0378-9123-16	FENTANYL	72 h in 1 PATCH	PATCH	72	27
0378-9123-98	FENTANYL	5 in 1 CARTON	PATCH	5	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-9123-16	EA - Each	0378-9123	1cb0bc84-6697-4cff-ae04-03cc3f60672b	1	2012-07-24
0378-9123-98	EA - Each	0378-9123	06b0999b-eccc-436e-baae-183cc175d755	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENTANYL	ACTIVE INGREDIENT	UF599785JZ	FENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]	9
FENTANYL	ACTIVE MOIETY	UF599785JZ	FENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]	9
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	FENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]	9
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W)	INACTIVE INGREDIENT	9N5G1G3D3H	FENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]	9
FENTANYL	ACTIVE INGREDIENT	UF599785JZ	FENTANYL PATCH [PHYSICIANS TOTAL CARE, INC.]	2
FENTANYL	ACTIVE MOIETY	UF599785JZ	FENTANYL PATCH [PHYSICIANS TOTAL CARE, INC.]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	FENTANYL PATCH [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-9123	FENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]	23	Current NDC, Legacy NDC, 3 package rows	20241019_2a2238e9-4b5d-c56d-8663-dd354ff9ae0c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENTANYL	FENTANYL	Mylan Pharmaceuticals Inc.	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	2025-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076258 application number: ANDA076258 ndc (product): 0378-9123

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
245136	fentaNYL 100 MCG/HR 72HR Transdermal System	PSN	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
577057	fentaNYL 12 MCG/HR 72HR Transdermal System	PSN	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
245134	fentaNYL 25 MCG/HR 72HR Transdermal System	PSN	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
1603495	fentaNYL 37.5 MCG/HR 72HR Transdermal System	PSN	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
245135	fentaNYL 50 MCG/HR 72HR Transdermal System	PSN	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
1603498	fentaNYL 62.5 MCG/HR 72 HR Transdermal System	PSN	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
197696	fentaNYL 75 MCG/HR 72HR Transdermal System	PSN	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
1603501	fentaNYL 87.5 MCG/HR 72HR Transdermal System	PSN	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
577057	72 HR fentanyl 0.012 MG/HR Transdermal System	SCD	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
245134	72 HR fentanyl 0.025 MG/HR Transdermal System	SCD	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
1603495	72 HR fentanyl 0.0375 MG/HR Transdermal System	SCD	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
245135	72 HR fentanyl 0.05 MG/HR Transdermal System	SCD	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
1603498	72 HR fentanyl 0.0625 MG/HR Transdermal System	SCD	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
197696	72 HR fentanyl 0.075 MG/HR Transdermal System	SCD	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
1603501	72 HR fentanyl 0.0875 MG/HR Transdermal System	SCD	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
245136	72 HR fentanyl 0.1 MG/HR Transdermal System	SCD	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
245136	fentanyl 100 MCG/HR 3 Day Transdermal Patch	SY	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
245136	fentanyl 100 MCG/HR 72HR Transdermal System	SY	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
577057	fentanyl 12 MCG/HR 3 Day Transdermal Patch	SY	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
577057	fentanyl 12 MCG/HR 72HR Transdermal System	SY	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
245134	fentanyl 25 MCG/HR 3 Day Transdermal Patch	SY	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
245134	fentanyl 25 MCG/HR 72HR Transdermal System	SY	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
1603495	fentanyl 37.5 MCG/HR 3 Day Transdermal Patch	SY	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
1603495	fentaNYL 37.5 MCG/HR 72HR Transdermal System	SY	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
245135	fentanyl 50 MCG/HR 3 Day Transdermal Patch	SY	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
245135	fentanyl 50 MCG/HR 72HR Transdermal System	SY	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
1603498	fentanyl 62.5 MCG/HR 3 Day Transdermal Patch	SY	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
1603498	fentanyl 62.5 MCG/HR 72 HR Transdermal System	SY	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
197696	fentanyl 75 MCG/HR 3 Day Transdermal Patch	SY	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
197696	fentanyl 75 MCG/HR 72HR Transdermal System	SY	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
1603501	fentanyl 87.5 MCG/HR 3 Day Transdermal Patch	SY	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
1603501	fentanyl 87.5 MCG/HR 72HR Transdermal System	SY	2a2238e9-4b5d-c56d-8663-dd354ff9ae0c	27
245136	fentaNYL 100 MCG/HR 72HR Transdermal System	PSN	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
577057	fentaNYL 12 MCG/HR 72HR Transdermal System	PSN	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
245134	fentaNYL 25 MCG/HR 72HR Transdermal System	PSN	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
245135	fentaNYL 50 MCG/HR 72HR Transdermal System	PSN	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
197696	fentaNYL 75 MCG/HR 72HR Transdermal System	PSN	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
577057	72 HR fentanyl 0.012 MG/HR Transdermal System	SCD	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
245134	72 HR fentanyl 0.025 MG/HR Transdermal System	SCD	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
245135	72 HR fentanyl 0.05 MG/HR Transdermal System	SCD	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
197696	72 HR fentanyl 0.075 MG/HR Transdermal System	SCD	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
245136	72 HR fentanyl 0.1 MG/HR Transdermal System	SCD	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
245136	fentanyl 100 MCG/HR 3 Day Transdermal Patch	SY	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
245136	fentanyl 100 MCG/HR 72HR Transdermal System	SY	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
577057	fentanyl 12 MCG/HR 3 Day Transdermal Patch	SY	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
577057	fentanyl 12 MCG/HR 72HR Transdermal System	SY	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
245134	fentanyl 25 MCG/HR 3 Day Transdermal Patch	SY	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
245134	fentanyl 25 MCG/HR 72HR Transdermal System	SY	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
245135	fentanyl 50 MCG/HR 3 Day Transdermal Patch	SY	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
245135	fentanyl 50 MCG/HR 72HR Transdermal System	SY	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
197696	fentanyl 75 MCG/HR 3 Day Transdermal Patch	SY	b7fe401c-7ddc-4391-9cff-3608da03e86b	2
197696	fentanyl 75 MCG/HR 72HR Transdermal System	SY	b7fe401c-7ddc-4391-9cff-3608da03e86b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-9123-16	00378912316	1 in 1 POUCH						Historical
0378-9123-98	00378912398	5 POUCH in 1 CARTON (0378-9123-98) / 1 PATCH in 1 POUCH (0378-9123-16) / 72 h in 1 PATCH	5 pouch	2005-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FENTANYL - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2025-12-15	HUMAN PRESCRIPTION DRUG LABEL	27
FENTANYL - Quality Care Products, LLC	Quality Care Products, LLC	2019-10-22	HUMAN PRESCRIPTION DRUG LABEL	6
Fentanyl - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2009-12-16	HUMAN PRESCRIPTION DRUG LABEL	2