Vancomycin Hydrochloride

Product NDC: 0409-6531
11-digit product format: 004096531
Labeler code: 0409
Product ID: 0409-6531_10032a19-0373-4c42-b785-f3d915614e30
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VANCOMYCIN HYDROCHLORIDE
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Hospira, Inc.
Application: ANDA062912
Marketing category: ANDA
Marketing start: 2009-03-27
Substance: VANCOMYCIN HYDROCHLORIDE
Active strength: 750 mg/1
Pharmacologic classes: Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Vancomycin Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VANCOMYCIN HYDROCHLORIDE	750 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	71WO621TJD
Rxcui	1807513, 1807516, 1807518, 2049890

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
0409-6531-02	Vancomycin Hydrochloride	10 in 1 TRAY	INJECTION, POWDER, LYOPHILIZED,	10		37
0409-6531-12	Vancomycin Hydrochloride	1 in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	1		37
0409-6531-01	Vancomycin Hydrochloride	10 in 1 TRAY	INJECTION, POWDER, LYOPHILIZED,	10		35
0409-6531-11	Vancomycin Hydrochloride	1 in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1		35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-6531-01	EA - Each	0409-6531	1bdd7e9e-0919-49e0-8bf1-e38e3b73e2c1	1	2013-02-13
0409-6531-02	EA - Each	0409-6531	e393ac1f-81cb-4152-bd7f-2bbae494d641	1	2012-07-24
0409-6531-11	EA - Each	0409-6531	4645c6ca-87ce-4beb-bfbc-446436917023	1	2019-11-12
0409-6531-12	EA - Each	0409-6531	bf9e9b50-fcc6-4df8-9dea-4bbede3ef787	1	2019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
VANCOMYCIN HYDROCHLORIDE	ACTIVE INGREDIENT	71WO621TJD	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]	18
VANCOMYCIN	ACTIVE MOIETY	6Q205EH1VU	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]	18
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]	18
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]	18
VANCOMYCIN HYDROCHLORIDE	ACTIVE INGREDIENT	71WO621TJD	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]	17
VANCOMYCIN	ACTIVE MOIETY	6Q205EH1VU	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]	17
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]	17
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]	17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-6531	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]	36	Current NDC, Legacy NDC, 2 package rows	20250109_f2901045-904f-47bd-74a1-c561facd7f25.zip
0409-6531	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]	34	Current NDC, Legacy NDC, 2 package rows	20250116_2fd9de3f-a95f-451c-a687-d2e1306e53bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1807513	vancomycin 1 GM Injection	PSN	f2901045-904f-47bd-74a1-c561facd7f25	37
2049890	vancomycin 1.5 GM Injection	PSN	f2901045-904f-47bd-74a1-c561facd7f25	37
1807516	vancomycin 500 MG Injection	PSN	f2901045-904f-47bd-74a1-c561facd7f25	37
1807518	vancomycin 750 MG Injection	PSN	f2901045-904f-47bd-74a1-c561facd7f25	37
1807513	vancomycin 1000 MG Injection	SCD	f2901045-904f-47bd-74a1-c561facd7f25	37
2049890	vancomycin 1500 MG Injection	SCD	f2901045-904f-47bd-74a1-c561facd7f25	37
1807516	vancomycin 500 MG Injection	SCD	f2901045-904f-47bd-74a1-c561facd7f25	37
1807518	vancomycin 750 MG Injection	SCD	f2901045-904f-47bd-74a1-c561facd7f25	37
1807513	vancomycin (as vancomycin HCl) 1 GM Injection	SY	f2901045-904f-47bd-74a1-c561facd7f25	37
1807516	vancomycin (as vancomycin HCl) 500 MG Injection	SY	f2901045-904f-47bd-74a1-c561facd7f25	37
1807513	vancomycin 1 GM Injection	SY	f2901045-904f-47bd-74a1-c561facd7f25	37
2049890	vancomycin 1.5 GM (as vancomycin hydrochloride 1.54 GM) Injection	SY	f2901045-904f-47bd-74a1-c561facd7f25	37
2049890	vancomycin 1.5 GM Injection	SY	f2901045-904f-47bd-74a1-c561facd7f25	37
1807518	vancomycin 750 MG (as vancomycin hydrochloride 769 MG) Injection	SY	f2901045-904f-47bd-74a1-c561facd7f25	37

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-6531-01	00409653101	10 VIAL, SINGLE-DOSE in 1 TRAY (0409-6531-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-6531-11)		2012-03-23	0000-00-00	No	No	Current
0409-6531-02	00409653102	10 VIAL in 1 TRAY (0409-6531-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0409-6531-12)	10 vial	2009-03-27	0000-00-00	No	No	Current
0409-6531-11	00409653111	1 in 1 VIAL, SINGLE-DOSE						Historical
0409-6531-12	00409653112	1 in 1 VIAL						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vancomycin Hydrochloride for Injection, USP	Hospira, Inc.	2026-05-18	HUMAN PRESCRIPTION DRUG LABEL	35
Vancomycin Hydrochloride for Injection, USP Fliptop Vial For Intravenous Use	Hospira, Inc.	2026-04-01	HUMAN PRESCRIPTION DRUG LABEL	37