Fentanyl System

Product NDC: 55700-972
11-digit product format: 557000972
Labeler code: 55700
Product ID: 55700-972_22e0f964-22f3-4222-b432-1b41ea03a113
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fentanyl
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Quality Care Products, LLC
Application: ANDA202097
Marketing category: ANDA
Marketing start: 2022-05-09
Marketing end: 0000-00-00
Substance: FENTANYL
Active strength: 13 ug/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	55700-972		D	Discontinued by firm		2026-08-03
excluded package	package	55700-972	55700-972-05	D	Discontinued by firm		2026-08-03

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 4 · 155 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202097-001	FENTANYL-12	12.5MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202097-002	FENTANYL-25	25MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202097-003	FENTANYL-50	50MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202097-004	FENTANYL-75	75MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202097-005	FENTANYL-100	100MCG/HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB	2016-11-04	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 155 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202097-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202097-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202097-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202097-004	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202097-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202097-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202097-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202097-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202097-004	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202097-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202097-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202097-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202097-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202097-004	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202097-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202097-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202097-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202097-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202097-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202097-005	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202097-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202097-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202097-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202097-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202097-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202097-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202097-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202097-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202097-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202097-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202097-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202097-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202097-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202097-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202097-005	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202097-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202097-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202097-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202097-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202097-005	AB	1	`74a2ff9319b5…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55700-972-05	2025-01-13	C162847	48780-1	1030e365-5a1e-111a-e063-dadaa90a10e2	FENTANYL TRANSDERMAL SYSTEM, CII Initial U.S. Approval: 1968 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.
55700-972-05	2024-01-30	C162847	48780-1	1030e365-5a1e-111a-e063-dadaa90a10e2	FENTANYL TRANSDERMAL SYSTEM, CII Initial U.S. Approval: 1968 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.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-972-05	EA - Each	55700-972	873608dc-e8e6-4972-88f3-2dd3e5b807e2	1	2022-09-12

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
55700-972-05	55700097205	1 POUCH in 1 CARTON (55700-972-05) > 5 PATCH in 1 POUCH	1 pouch	2022-05-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fentanyl System - Quality Care Products, LLC	Quality Care Products, LLC	2025-01-13	HUMAN PRESCRIPTION DRUG LABEL	2