National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 02:44:14

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50458-091-05	EA - Each	50458-091	d1cfbac8-0377-47da-941d-e68c716ce297	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50458-091	50458-091-05

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N019813-001	DURAGESIC-100	FENTANYL	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07
N019813-002	DURAGESIC-75	FENTANYL	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07
N019813-003	DURAGESIC-50	FENTANYL	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07
N019813-004	DURAGESIC-25	FENTANYL	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07
N019813-005	DURAGESIC-12	FENTANYL	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04
N019813-006	DURAGESIC-37	FENTANYL	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-005	DURAGESIC-12	12.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2005-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019813-006	DURAGESIC-37	37.5MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	2018-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019813-001	DURAGESIC-100	100MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019813-002	DURAGESIC-75	75MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019813-003	DURAGESIC-50	50MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019813-004	DURAGESIC-25	25MCG/HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD	1990-08-07	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019813-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019813-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019813-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019813-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019813-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019813-006	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019813-006	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019813-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019813-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019813-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019813-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019813-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019813-006	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019813-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019813-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019813-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019813-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019813-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019813-006	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019813-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019813-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019813-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019813-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019813-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019813-006	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019813-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019813-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019813-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019813-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019813-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019813-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019813-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019813-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019813-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019813-004	AB	1	`b00525d2431f…`

Reported adverse events (FAERS/openFDA)#

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