Vancomycin Hydrochloride

Product NDC: 0781-3187
Requested package NDC: 0781-3187-95
11-digit product format: 007813187
Labeler code: 0781
Product ID: 0781-3187_85418ecb-652c-4790-a9ea-6462de126db7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vancomycin Hydrochloride
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Sandoz Inc
Application: ANDA090250
Marketing category: ANDA
Marketing start: 2010-04-27
Marketing end: 0000-00-00
Substance: VANCOMYCIN HYDROCHLORIDE
Active strength: 500 mg/10mL
Pharmacologic classes: Glycopeptide Antibacterial [EPC],Glycopeptides [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0781-3187	0781-3187-95	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A090250-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			2010-04-27
A090250-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION			2010-04-27

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2010-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-04-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-04-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-04-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090250-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2010-04-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090250-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2010-04-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090250-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090250-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090250-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090250-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090250-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090250-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090250-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090250-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090250-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090250-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090250-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090250-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090250-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090250-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090250-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090250-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090250-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090250-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090250-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090250-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090250-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090250-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090250-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090250-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090250-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090250-002	AP	1	`ea99ee380514…`
2022-10-28 04:53 UTC	2022-10	A090250-001	AP	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090250-002	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090250-001	AP	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090250-002	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090250-001	AP	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090250-002	AP	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-3187-70	EA - Each	0781-3187	70d81ceb-f542-479d-892c-ff3cb6d3a22a	1	2012-07-24
0781-3187-95	EA - Each	0781-3187	5c4e8592-4ff0-4ec4-96f3-a14433b1fb29	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VANCOMYCIN HYDROCHLORIDE	ACTIVE INGREDIENT	71WO621TJD	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC]	6
VANCOMYCIN	ACTIVE MOIETY	6Q205EH1VU	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC]	6
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC]	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC]	6

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	Plano Pharmaceuticals Inc.	4983e3c8-e0f2-b366-e063-6394a90a9557	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090250 application number: ANDA090250

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
71WO621TJD	VANCOMYCIN HYDROCHLORIDE	1404-93-9	VANCOMYCIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-3187-95	00781318795	10 VIAL in 1 CARTON (0781-3187-95) > 10 mL in 1 VIAL (0781-3187-70)	10 vial	2010-04-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vancomycin Hydrochloride for Injection, USP Fliptop Vial for Intravenous Use	Sandoz Inc	2015-09-28	HUMAN PRESCRIPTION DRUG LABEL	7