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 01:26:38

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
62856-797-01	ML - Milliliter	62856-797	2e85bbe2-494b-4ac7-91b2-e5a8f0735129	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62856-797	62856-797-01

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
N021372-001	ALOXI	PALONOSETRON HYDROCHLORIDE	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25
N021372-002	ALOXI	PALONOSETRON HYDROCHLORIDE	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29

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 · 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	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2003-07-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS		RLD	2008-02-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021372-001	ALOXI	EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2003-07-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021372-002	ALOXI	EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2008-02-29	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021372-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021372-002	AP	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021372-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021372-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021372-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021372-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021372-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021372-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021372-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021372-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021372-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021372-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021372-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021372-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021372-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021372-002	AP	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 37 · 1,470 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7947724	2024-01-30		Drug product	2011-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7947725	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7960424	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8518981	2024-01-30		Drug product	2013-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8598218	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8598219	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8729094	2024-01-30	U-528	Drug product	2014-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9066980	2024-01-30	U-528	Drug product	2015-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9125905	2024-01-30		Drug product	2015-09-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9173942	2024-01-30		Drug product	2015-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9439854	2024-01-30		Drug product	2016-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9457020	2024-01-30		Drug product	2016-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9457021	2024-01-30		Drug product	2016-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7947724*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7947725*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	7960424*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8518981*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8598218*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8598219*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	8729094*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9066980*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9125905*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9173942*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9439854*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9457020*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-001	9457021*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7947724	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7947725	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7960424	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	8518981	2024-01-30		Drug product	2013-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	8598218	2024-01-30		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	9173942	2024-01-30		Drug product	2015-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	9439854	2024-01-30		Drug product	2016-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	9457020	2024-01-30		Drug product	2016-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7947724*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7947725*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	7960424*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	8518981*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	8598218*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021372-002	9173942*PED	2024-07-30		Pediatric extension		`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

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