National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2013-02-13
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 03:22:54

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
50419-788-01	EA - Each	50419-788	cd495c6d-a5fa-4069-b106-d2242dfe4e2a	1	2013-02-13

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50419-788	50419-788-01

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021473-001	CIPRO XR	CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL			2002-12-13
N021473-002	CIPRO XR	CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL			2003-08-28

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021473-001	CIPRO XR	212.6MG;EQ 287.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	2002-12-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021473-002	CIPRO XR	425.2MG;EQ 574.9MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, EXTENDED RELEASE / ORAL	2003-08-28	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021473-001	7709022	2021-06-23	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021473-001	8187632	2021-06-23	Drug product	2013-06-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021473-001	7709022*PED	2021-12-23	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021473-001	8187632*PED	2021-12-23	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021473-002	7709022	2021-06-23	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021473-002	8187632	2021-06-23	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021473-002	7709022*PED	2021-12-23	Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021473-002	8187632*PED	2021-12-23	Pediatric extension		`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021473-001	7709022	2021-06-23	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021473-001	8187632	2021-06-23	Drug product	2013-06-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021473-001	7709022*PED	2021-12-23	Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021473-001	8187632*PED	2021-12-23	Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021473-002	7709022	2021-06-23	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021473-002	8187632	2021-06-23	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021473-002	7709022*PED	2021-12-23	Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021473-002	8187632*PED	2021-12-23	Pediatric extension		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021473-001	7709022	2021-06-23	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021473-001	8187632	2021-06-23	Drug product	2013-06-20	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021473-001	7709022*PED	2021-12-23	Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021473-001	8187632*PED	2021-12-23	Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021473-002	7709022	2021-06-23	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021473-002	8187632	2021-06-23	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021473-002	7709022*PED	2021-12-23	Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021473-002	8187632*PED	2021-12-23	Pediatric extension		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021473-001	7709022	2021-06-23	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021473-001	8187632	2021-06-23	Drug product	2013-06-20	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021473-001	7709022*PED	2021-12-23	Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021473-001	8187632*PED	2021-12-23	Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021473-002	7709022	2021-06-23	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021473-002	8187632	2021-06-23	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021473-002	7709022*PED	2021-12-23	Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021473-002	8187632*PED	2021-12-23	Pediatric extension		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021473-001	7709022	2021-06-23	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021473-001	8187632	2021-06-23	Drug product	2013-06-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021473-001	7709022*PED	2021-12-23	Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021473-001	8187632*PED	2021-12-23	Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021473-002	7709022	2021-06-23	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021473-002	8187632	2021-06-23	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021473-002	7709022*PED	2021-12-23	Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021473-002	8187632*PED	2021-12-23	Pediatric extension		`8869cabd3fbd…`

Reported adverse events (FAERS/openFDA)#

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