Application 050671

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 500MG BASE/100ML	Yes	Yes
002	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 750MG BASE/150ML	Yes	Yes
003	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1GM BASE/200ML	Yes	Yes
004	VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)	Yes	Yes
005	VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N050671-001	VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/100ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	1993-04-29
N050671-002	VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/150ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2010-12-20
N050671-003	VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/200ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	1999-03-01
N050671-004	VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-01-25
N050671-005	VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-01-25

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 4 of 5 · 170 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-09-15 20:21 UTC	2019-09	N050671-003	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 1GM BASE/200ML	INJECTABLE / INJECTION	RLD, RS	1999-03-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050671-001	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1993-04-29	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050671-002	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 750MG BASE/150ML	INJECTABLE / INJECTION	RLD, RS	2010-12-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050671-003	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 1GM BASE/200ML	INJECTABLE / INJECTION	RLD, RS	1999-03-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050671-001	VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 500MG BASE/100ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	1993-04-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050671-002	VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 750MG BASE/150ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2010-12-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050671-003	VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 1GM BASE/200ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	1999-03-01	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050671-004	VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-01-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050671-005	VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050671-001	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1993-04-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050671-002	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 750MG BASE/150ML	INJECTABLE / INJECTION	RLD, RS	2010-12-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050671-003	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 1GM BASE/200ML	INJECTABLE / INJECTION	RLD, RS	1999-03-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050671-001	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1993-04-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050671-002	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 750MG BASE/150ML	INJECTABLE / INJECTION	RLD, RS	2010-12-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050671-003	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 1GM BASE/200ML	INJECTABLE / INJECTION	RLD, RS	1999-03-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050671-001	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1993-04-29	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050671-002	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 750MG BASE/150ML	INJECTABLE / INJECTION	RLD, RS	2010-12-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050671-003	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 1GM BASE/200ML	INJECTABLE / INJECTION	RLD, RS	1999-03-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050671-001	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1993-04-29	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050671-002	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 750MG BASE/150ML	INJECTABLE / INJECTION	RLD, RS	2010-12-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050671-003	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 1GM BASE/200ML	INJECTABLE / INJECTION	RLD, RS	1999-03-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050671-001	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1993-04-29	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050671-002	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 750MG BASE/150ML	INJECTABLE / INJECTION	RLD, RS	2010-12-20	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050671-003	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 1GM BASE/200ML	INJECTABLE / INJECTION	RLD, RS	1999-03-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050671-001	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1993-04-29	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050671-002	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 750MG BASE/150ML	INJECTABLE / INJECTION	RLD, RS	2010-12-20	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050671-003	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 1GM BASE/200ML	INJECTABLE / INJECTION	RLD, RS	1999-03-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050671-001	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1993-04-29	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050671-002	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 750MG BASE/150ML	INJECTABLE / INJECTION	RLD, RS	2010-12-20	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050671-003	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 1GM BASE/200ML	INJECTABLE / INJECTION	RLD, RS	1999-03-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050671-001	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1993-04-29	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050671-002	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 750MG BASE/150ML	INJECTABLE / INJECTION	RLD, RS	2010-12-20	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050671-003	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 1GM BASE/200ML	INJECTABLE / INJECTION	RLD, RS	1999-03-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050671-001	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1993-04-29	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050671-002	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 750MG BASE/150ML	INJECTABLE / INJECTION	RLD, RS	2010-12-20	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050671-003	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 1GM BASE/200ML	INJECTABLE / INJECTION	RLD, RS	1999-03-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050671-001	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1993-04-29	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050671-002	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 750MG BASE/150ML	INJECTABLE / INJECTION	RLD, RS	2010-12-20	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N050671-003	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 1GM BASE/200ML	INJECTABLE / INJECTION	RLD, RS	1999-03-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050671-001	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER	EQ 500MG BASE/100ML	INJECTABLE / INJECTION	RLD, RS	1993-04-29	`e64feba35796…`

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
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	99e523d8-9bde-43cb-8434-497015e5dcbd	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050671 application number: NDA050671 ndc (product): 0338-3552 ndc (product): 0338-3580 ndc (product): 0338-3581 ndc (product): 0338-3551 ndc (product): 0338-3582 ndc (product): 0338-3583

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-3551	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3551	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3551	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3551	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3551	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3552	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3552	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3552	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3552	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3552	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3580	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3580	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3580	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3580	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3580	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3581	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3581	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3581	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3581	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3581	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3582	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3582	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3582	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3582	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3582	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3583	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3583	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3583	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3583	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current
0338-3583	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82368	ORIG	2025-05-30
82367	SUPPL	2025-05-30
82361	SUPPL	2025-05-30
78752	SUPPL	2024-07-02
78760	SUPPL	2024-06-10
66045	SUPPL	2021-02-01
66031	SUPPL	2021-02-01
49893	SUPPL	2017-09-29
49879	SUPPL	2017-09-29
46852	SUPPL	2017-01-17
46767	SUPPL	2017-01-06
17999	SUPPL	2015-12-28
7966	SUPPL	2015-12-22
17998	SUPPL	2012-01-23
7965	SUPPL	2012-01-19
39086	SUPPL	2009-04-03
30250	SUPPL	2009-03-13
39085	SUPPL	2008-05-08
7964	SUPPL	2008-05-07
30249	SUPPL	2007-09-25
39084	SUPPL	2007-09-19
7963	SUPPL	2004-04-07
17997	SUPPL	2004-04-05
42672	SUPPL	1998-01-08
42671	SUPPL	1998-01-08