VANCOMYCIN HYDROCHLORIDE

Product NDC: 71467-014
Requested package NDC: 71467-014-01
11-digit product format: 714670014
Labeler code: 71467
Product ID: 71467-014_0d42a289-5edd-413e-8493-67d2c0154234
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vancomycin hydrochloride
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS; ORAL
Labeler: Zhejiang Novus Pharma Co., Ltd.
Application: NDA210274
Marketing category: NDA
Marketing start: 2024-08-23
Substance: VANCOMYCIN HYDROCHLORIDE
Active strength: 10.25 g/g
Pharmacologic classes: Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 9 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
2025-04-01 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…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N210274-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20
N210274-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20
N210274-003	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20
N210274-004	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20
N210274-005	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2025-08-01
N210274-006	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2025-08-01
N210274-007	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.5MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2025-08-01

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 · 101 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210274-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210274-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210274-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210274-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210274-005	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2025-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210274-006	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2025-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210274-007	VANCOMYCIN HYDROCHLORIDE	EQ 1.5MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2025-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210274-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210274-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210274-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210274-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210274-005	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2025-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210274-006	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2025-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210274-007	VANCOMYCIN HYDROCHLORIDE	EQ 1.5MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2025-08-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210274-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210274-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210274-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210274-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210274-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210274-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210274-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210274-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210274-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210274-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210274-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210274-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210274-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210274-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210274-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210274-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210274-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210274-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210274-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210274-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210274-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210274-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210274-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210274-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210274-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210274-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: VANCOMYCIN HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VANCOMYCIN HYDROCHLORIDE	10.25 g/g

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	HIKMA PHARMACEUTICALS USA INC.	8eccafe8-40c9-495a-872d-7f45a98ee759	2025-08-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210274 application number: NDA210274
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	HIKMA PHARMACEUTICALS USA INC.	e4ce7b87-fab4-4b7a-b121-eba136c464ce	2024-08-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210274 application number: NDA210274

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	Marketing start	Sample	Exclude flag	Status
71467-014-01	71467001401	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71467-014-01) / 10.25 g in 1 VIAL, PHARMACY BULK PACKAGE	2024-08-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VANCOMYCIN HYDROCHLORIDE	Zhejiang Novus Pharma Co., Ltd.	2023-05-05	HUMAN PRESCRIPTION DRUG LABEL	1