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 02:55:33

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
0069-0145-01	EA - Each	0069-0145	e131dc70-c75a-457e-a8ff-afacd24dd2b9	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0069-0145	0069-0145-01

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
N202324-001	INLYTA	AXITINIB	1MG	TABLET / ORAL		RLD	2012-01-27
N202324-002	INLYTA	AXITINIB	5MG	TABLET / ORAL		RLD, RS	2012-01-27

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202324-001	8791140	2030-12-14		Drug substance
N202324-001	8791140*PED	2031-06-14		Pediatric extension
N202324-001	10570202	2035-02-03	U-2844		2020-06-30
N202324-001	12534530	2035-02-03	U-4411		2026-02-23
N202324-001	12534530	2035-02-03	U-4412		2026-02-23
N202324-001	10570202*PED	2035-08-03		Pediatric extension
N202324-001	12534530*PED	2035-08-03		Pediatric extension
N202324-001	10869924	2037-01-12	U-3044		2021-01-21
N202324-001	10869924*PED	2037-07-12		Pediatric extension
N202324-002	8791140	2030-12-14		Drug substance
N202324-002	8791140*PED	2031-06-14		Pediatric extension
N202324-002	10570202	2035-02-03	U-2844		2020-06-30
N202324-002	12534530	2035-02-03	U-4411		2026-02-23
N202324-002	12534530	2035-02-03	U-4412		2026-02-23
N202324-002	10570202*PED	2035-08-03		Pediatric extension
N202324-002	12534530*PED	2035-08-03		Pediatric extension
N202324-002	10869924	2037-01-12	U-3044		2021-01-21
N202324-002	10869924*PED	2037-07-12		Pediatric extension

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202324-001	INLYTA	1MG	TABLET / ORAL	AB	RLD	2012-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-002	INLYTA	5MG	TABLET / ORAL	AB	RLD, RS	2012-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-001	INLYTA	1MG	TABLET / ORAL	AB	RLD	2012-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-002	INLYTA	5MG	TABLET / ORAL	AB	RLD, RS	2012-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202324-001	INLYTA	1MG	TABLET / ORAL		RLD	2012-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202324-002	INLYTA	5MG	TABLET / ORAL		RLD, RS	2012-01-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202324-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202324-002	AB	1	`31067a03dcf5…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 450 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N202324-001	8791140	2030-12-14		Drug substance		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-001	8791140*PED	2031-06-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-001	10570202	2035-02-03	U-2844		2020-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-001	12534530	2035-02-03	U-4411		2026-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-001	12534530	2035-02-03	U-4412		2026-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-001	10570202*PED	2035-08-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-001	12534530*PED	2035-08-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-001	10869924	2037-01-12	U-3044		2021-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-001	10869924*PED	2037-07-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-002	8791140	2030-12-14		Drug substance		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-002	8791140*PED	2031-06-14		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-002	10570202	2035-02-03	U-2844		2020-06-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-002	12534530	2035-02-03	U-4411		2026-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-002	12534530	2035-02-03	U-4412		2026-02-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-002	10570202*PED	2035-08-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-002	12534530*PED	2035-08-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-002	10869924	2037-01-12	U-3044		2021-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202324-002	10869924*PED	2037-07-12		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202324-001	8791140	2030-12-14		Drug substance		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-001	8791140*PED	2031-06-14		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-001	10570202	2035-02-03	U-2844		2020-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-001	12534530	2035-02-03	U-4411		2026-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-001	12534530	2035-02-03	U-4412		2026-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-001	10570202*PED	2035-08-03		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-001	12534530*PED	2035-08-03		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-001	10869924	2037-01-12	U-3044		2021-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-001	10869924*PED	2037-07-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-002	8791140	2030-12-14		Drug substance		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-002	8791140*PED	2031-06-14		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-002	10570202	2035-02-03	U-2844		2020-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-002	12534530	2035-02-03	U-4411		2026-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-002	12534530	2035-02-03	U-4412		2026-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-002	10570202*PED	2035-08-03		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-002	12534530*PED	2035-08-03		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-002	10869924	2037-01-12	U-3044		2021-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202324-002	10869924*PED	2037-07-12		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202324-001	8791140	2030-12-14		Drug substance		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-001	8791140*PED	2031-06-14		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-001	10570202	2035-02-03	U-2844		2020-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202324-001	10570202*PED	2035-08-03		Pediatric extension		`011fe1cb6892…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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
INLYTA	AXITINIB	Pfizer Laboratories Div Pfizer Inc	84137882-e000-47da-bd5b-fa76ab3c76f9	2025-02-19	Warnings, Adverse reactions	Exact identifier ndc (package): 0069-0145-01 ndc11 (package): 00069014501

Reported adverse events (FAERS/openFDA)#

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