Fentanyl system

Product NDC: 47781-423
11-digit product format: 477810423
Labeler code: 47781
Product ID: 47781-423_4b8493ea-0ce4-6949-e063-6294a90a8861
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fentanyl
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: ALVOGEN
Application: ANDA202097
Marketing category: ANDA
Marketing start: 2016-11-04
Substance: FENTANYL
Active strength: 12.5 ug/1
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202097-001	FENTANYL-12	FENTANYL	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04
A202097-002	FENTANYL-25	FENTANYL	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04
A202097-003	FENTANYL-50	FENTANYL	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04
A202097-004	FENTANYL-75	FENTANYL	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04
A202097-005	FENTANYL-100	FENTANYL	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A202097-001	AB
A202097-002	AB
A202097-003	AB
A202097-004	AB
A202097-005	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 6 · 205 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	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A202097-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202097-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202097-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202097-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202097-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202097-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202097-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202097-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202097-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202097-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202097-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202097-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202097-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202097-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202097-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202097-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202097-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202097-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202097-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202097-005	AB	1	`5bbf6a4d5a75…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 system	FENTANYL	ALVOGEN	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202097 application number: ANDA202097 ndc (product): 47781-423

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FENTANYL	12.5 ug/1

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 · 5 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

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
242759ef-cb6d-4e3e-9f8d-5e31efa1f289	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
47781-423-11	Fentanyl system	1 in 1 POUCH	PATCH	1		27
47781-423-47	Fentanyl system	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
47781-423-11	EA - Each	47781-423	3dcf4c61-0329-4bb0-9b24-1a8f6340416e	1	2018-05-09
47781-423-47	EA - Each	47781-423	2b9bc5a3-c140-4653-ba12-a4c9fc175bcb	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47781-423	FENTANYL SYSTEM (FENTANYL) PATCH [ALVOGEN]	24	Current NDC, Legacy NDC, 2 package rows	20241027_242759ef-cb6d-4e3e-9f8d-5e31efa1f289.zip

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	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
577057	fentaNYL 12 MCG/HR 72HR Transdermal System	PSN	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
245134	fentaNYL 25 MCG/HR 72HR Transdermal System	PSN	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
245135	fentaNYL 50 MCG/HR 72HR Transdermal System	PSN	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
197696	fentaNYL 75 MCG/HR 72HR Transdermal System	PSN	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
577057	72 HR fentanyl 0.012 MG/HR Transdermal System	SCD	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
245134	72 HR fentanyl 0.025 MG/HR Transdermal System	SCD	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
245135	72 HR fentanyl 0.05 MG/HR Transdermal System	SCD	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
197696	72 HR fentanyl 0.075 MG/HR Transdermal System	SCD	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
245136	72 HR fentanyl 0.1 MG/HR Transdermal System	SCD	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
245136	fentanyl 100 MCG/HR 3 Day Transdermal Patch	SY	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
245136	fentanyl 100 MCG/HR 72HR Transdermal System	SY	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
577057	fentanyl 12 MCG/HR 3 Day Transdermal Patch	SY	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
577057	fentanyl 12 MCG/HR 72HR Transdermal System	SY	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
245134	fentanyl 25 MCG/HR 3 Day Transdermal Patch	SY	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
245134	fentanyl 25 MCG/HR 72HR Transdermal System	SY	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
245135	fentanyl 50 MCG/HR 3 Day Transdermal Patch	SY	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
245135	fentanyl 50 MCG/HR 72HR Transdermal System	SY	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
197696	fentanyl 75 MCG/HR 3 Day Transdermal Patch	SY	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27
197696	fentanyl 75 MCG/HR 72HR Transdermal System	SY	242759ef-cb6d-4e3e-9f8d-5e31efa1f289	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47781-423-11	47781042311	1 in 1 POUCH						Historical
47781-423-47	47781042347	5 POUCH in 1 CARTON (47781-423-47) / 1 PATCH in 1 POUCH (47781-423-11)	5 pouch	2016-11-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fentanyl system - ALVOGEN \| Kindeva Drug Delivery L.P.	ALVOGEN \| Kindeva Drug Delivery L.P.	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL	27
Fentanyl System - Quality Care Products, LLC	Quality Care Products, LLC	2025-01-13	HUMAN PRESCRIPTION DRUG LABEL	2