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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-972DDiscontinued by firm2026-08-03
excluded packagepackage55700-97255700-972-05DDiscontinued by firm2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202097-001FENTANYL-12FENTANYL12.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04
A202097-002FENTANYL-25FENTANYL25MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04
A202097-003FENTANYL-50FENTANYL50MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04
A202097-004FENTANYL-75FENTANYL75MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04
A202097-005FENTANYL-100FENTANYL100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202097-001AB
A202097-002AB
A202097-003AB
A202097-004AB
A202097-005AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202097-001FENTANYL-1212.5MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202097-002FENTANYL-2525MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202097-003FENTANYL-5050MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202097-004FENTANYL-7575MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202097-005FENTANYL-100100MCG/HRFILM, EXTENDED RELEASE / TRANSDERMALAB2016-11-0474a2ff9319b5…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202097-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202097-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202097-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202097-004AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202097-005AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202097-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202097-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202097-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202097-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202097-005AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202097-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202097-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202097-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202097-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202097-005AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202097-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202097-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202097-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202097-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202097-005AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202097-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202097-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202097-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202097-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202097-005AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202097-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202097-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202097-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202097-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202097-005AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202097-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202097-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202097-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202097-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202097-005AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202097-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202097-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202097-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202097-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202097-005AB174a2ff9319b5…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fentanyl systemFENTANYLALVOGEN242759ef-cb6d-4e3e-9f8d-5e31efa1f2892026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202097
application number: ANDA202097

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-972-05EA - Each55700-972873608dc-e8e6-4972-88f3-2dd3e5b807e212022-09-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-972-05557000972051 POUCH in 1 CARTON (55700-972-05) > 5 PATCH in 1 POUCH1 pouch2022-05-090000-00-00NoNoCurrent