VANCOMYCIN HYDROCHLORIDE

Product NDC: 0143-9163
11-digit product format: 001439163
Labeler code: 0143
Product ID: 0143-9163_0e6d2908-b33a-4f3e-a283-e8e1a2d38e5f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vancomycin hydrochloride
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS; ORAL
Labeler: HIKMA PHARMACEUTICALS USA INC.
Application: NDA210274
Marketing category: NDA
Marketing start: 2023-02-03
Substance: VANCOMYCIN HYDROCHLORIDE
Active strength: 5.13 g/g
Pharmacologic classes: Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 115 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N210274-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210274-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210274-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210274-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210274-005	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2025-08-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210274-006	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2025-08-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210274-007	VANCOMYCIN HYDROCHLORIDE	EQ 1.5MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2025-08-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210274-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210274-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210274-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210274-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2023-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210274-005	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2025-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210274-006	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2025-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210274-007	VANCOMYCIN HYDROCHLORIDE	EQ 1.5MG BASE/VIAL	POWDER / INTRAVENOUS, ORAL	RLD, RS	2025-08-01	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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	5.13 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
71WO621TJD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
239209	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e4ce7b87-fab4-4b7a-b121-eba136c464ce	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
518d3e87-1791-43fd-b421-7f508923e5f1	Product name	4	20260107
8c6bdc15-c879-407f-914d-b44fce8e7bbd	Product name	1	20240730
324cd4ef-8967-4991-91fd-3046d51874b9	Product name	2	20240118
ba2497d8-e8e9-d71b-251e-24ac323bbaa3	Product name	9	20231206
01f96903-8ada-4a91-9a58-9f8e51b7a70a	Product name	1	20230922
e5c5573a-2fda-453b-9d65-c6185b588ecd	Product name	5	20220613
3a86dfd0-ed28-4976-b9ec-00923fbfbdd4	Product name	1	20220308
5d603187-d384-6e74-5fc7-30310b2b3c99	Product name	3	20190717
bec007f0-8cd6-4f79-a3df-c0d94ebb2a36	Product name	1	20190614
f4fec0bc-aaaa-4c5c-aa2b-21daf18ef477	Product name	1	20160209
a0c54c75-e1f1-eb4f-25c4-be91c2fe237d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9163-01	VANCOMYCIN HYDROCHLORIDE	5.13 g in 1 VIAL, PHARMACY BULK PACKAGE	INJECTION, POWDER, FOR SOLUTION	5.13		4
0143-9163-01	VANCOMYCIN HYDROCHLORIDE	1 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9163-01	EA - Each	0143-9163	67c68a14-a676-4bc2-abf2-114689f5b244	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9163	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	4	Current NDC, 2 package rows	20240810_e4ce7b87-fab4-4b7a-b121-eba136c464ce.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Avenacy, LLC	c757e65b-ca6f-4c00-afe2-025962b43d31	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210274 application number: NDA210274
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 ndc (product): 0143-9163

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
239209	vancomycin 100 MG/ML Injectable Solution	PSN	e4ce7b87-fab4-4b7a-b121-eba136c464ce	4
239209	vancomycin 100 MG/ML Injectable Solution	SCD	e4ce7b87-fab4-4b7a-b121-eba136c464ce	4
239209	vancomycin (as vancomycin hydrochloride) 100 MG/ML Injectable Solution	SY	e4ce7b87-fab4-4b7a-b121-eba136c464ce	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0143-9163-01	00143916301	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0143-9163-01) / 5.13 g in 1 VIAL, PHARMACY BULK PACKAGE	2023-02-03	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VANCOMYCIN HYDROCHLORIDE	HIKMA PHARMACEUTICALS USA INC. \| Zhejiang Novus Pharmaceuticals Co., Ltd.	2024-08-07	HUMAN PRESCRIPTION DRUG LABEL	4