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 01:09:12

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
52544-248-28	EA - Each	52544-248	0e779339-d6a6-469c-952f-e3be9182894b	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52544-248	52544-248-28

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 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019653-001	ORTHO CYCLEN-21	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21			1989-12-29
N019653-002	ORTHO CYCLEN-28	ETHINYL ESTRADIOL; NORGESTIMATE	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28		RLD	1989-12-29

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-21		1989-12-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL-28	RLD	1989-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG	TABLET / ORAL-21		1989-12-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG	TABLET / ORAL-28	RLD	1989-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019653-001	ORTHO CYCLEN-21	0.035MG;0.25MG	TABLET / ORAL-21		1989-12-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019653-002	ORTHO CYCLEN-28	0.035MG;0.25MG	TABLET / ORAL-28	RLD	1989-12-29	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

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