Vancomycin Hydrochloride

Product NDC: 62559-830
11-digit product format: 625590830
Labeler code: 62559
Product ID: 62559-830_c02af1aa-0e2c-4174-9349-8838710838ee
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vancomycin Hydrochloride
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: ANDA061667
Marketing category: ANDA
Marketing start: 2019-09-09
Substance: VANCOMYCIN HYDROCHLORIDE
Active strength: 250 mg/5mL
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	250 mg/5mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	71WO621TJD
Rxcui	2000134

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
e5c5573a-2fda-453b-9d65-c6185b588ecd	Product name	5	20220613
3a86dfd0-ed28-4976-b9ec-00923fbfbdd4	Product name	1	20220308
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
5d603187-d384-6e74-5fc7-30310b2b3c99	Product name	3	20190717
bec007f0-8cd6-4f79-a3df-c0d94ebb2a36	Product name	1	20190614
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
f4fec0bc-aaaa-4c5c-aa2b-21daf18ef477	Product name	1	20160209
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
a0c54c75-e1f1-eb4f-25c4-be91c2fe237d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62559-830-03	Vancomycin Hydrochloride	300 mL in 1 BOTTLE, PLASTIC	POWDER, FOR SOLUTION	300	3
62559-830-55	Vancomycin Hydrochloride	150 mL in 1 BOTTLE, PLASTIC	POWDER, FOR SOLUTION	150	3
62559-830-80	Vancomycin Hydrochloride	80 mL in 1 BOTTLE, PLASTIC	POWDER, FOR SOLUTION	80	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62559-830	VANCOMYCIN HYDROCHLORIDE POWDER, FOR SOLUTION [ANI PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 3 package rows	20210303_27d06545-1af0-4dcd-926d-58d4a9492ec3.zip

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
2000134	vancomycin 50 MG/mL Oral Solution	PSN	786bde33-9aec-4b4d-ba46-90bfd61956d0	106
2000134	vancomycin 50 MG/ML Oral Solution	SCD	786bde33-9aec-4b4d-ba46-90bfd61956d0	106
2000134	vancomycin (as vancomycin hydrochloride) 50 MG/ML Oral Solution	SY	786bde33-9aec-4b4d-ba46-90bfd61956d0	106
2000134	vancomycin 15 GM per 289 ML Powder for Oral Solution	SY	786bde33-9aec-4b4d-ba46-90bfd61956d0	106
2000134	vancomycin 250 MG per 5 ML Powder for Oral Solution	SY	786bde33-9aec-4b4d-ba46-90bfd61956d0	106
2000134	vancomycin 7.5 GM per 145 ML Powder for Oral Solution	SY	786bde33-9aec-4b4d-ba46-90bfd61956d0	106
2000134	vancomycin 50 MG/mL Oral Solution	PSN	a09c589b-e7f4-457c-827f-e1bfa1b26700	105
2000134	vancomycin 50 MG/mL Oral Solution	PSN	9b6a7a21-4fde-40c6-a420-a8546a4dc701	105
2000134	vancomycin 50 MG/ML Oral Solution	SCD	a09c589b-e7f4-457c-827f-e1bfa1b26700	105
2000134	vancomycin 50 MG/ML Oral Solution	SCD	9b6a7a21-4fde-40c6-a420-a8546a4dc701	105
2000134	vancomycin (as vancomycin hydrochloride) 50 MG/ML Oral Solution	SY	a09c589b-e7f4-457c-827f-e1bfa1b26700	105
2000134	vancomycin (as vancomycin hydrochloride) 50 MG/ML Oral Solution	SY	9b6a7a21-4fde-40c6-a420-a8546a4dc701	105
2000134	vancomycin 15 GM per 289 ML Powder for Oral Solution	SY	9b6a7a21-4fde-40c6-a420-a8546a4dc701	105
2000134	vancomycin 15 GM per 289 ML Powder for Oral Solution	SY	a09c589b-e7f4-457c-827f-e1bfa1b26700	105
2000134	vancomycin 250 MG per 5 ML Powder for Oral Solution	SY	a09c589b-e7f4-457c-827f-e1bfa1b26700	105
2000134	vancomycin 250 MG per 5 ML Powder for Oral Solution	SY	9b6a7a21-4fde-40c6-a420-a8546a4dc701	105
2000134	vancomycin 7.5 GM per 145 ML Powder for Oral Solution	SY	a09c589b-e7f4-457c-827f-e1bfa1b26700	105
2000134	vancomycin 7.5 GM per 145 ML Powder for Oral Solution	SY	9b6a7a21-4fde-40c6-a420-a8546a4dc701	105
2000134	vancomycin 50 MG/mL Oral Solution	PSN	28fe3c01-cf87-41c0-87fd-f93a40524335	103
2000134	vancomycin 50 MG/ML Oral Solution	SCD	28fe3c01-cf87-41c0-87fd-f93a40524335	103
2000134	vancomycin (as vancomycin hydrochloride) 50 MG/ML Oral Solution	SY	28fe3c01-cf87-41c0-87fd-f93a40524335	103
2000134	vancomycin 15 GM per 289 ML Powder for Oral Solution	SY	28fe3c01-cf87-41c0-87fd-f93a40524335	103
2000134	vancomycin 250 MG per 5 ML Powder for Oral Solution	SY	28fe3c01-cf87-41c0-87fd-f93a40524335	103
2000134	vancomycin 7.5 GM per 145 ML Powder for Oral Solution	SY	28fe3c01-cf87-41c0-87fd-f93a40524335	103
2000134	vancomycin 50 MG/mL Oral Solution	PSN	6c74b360-022a-4c4d-9e4b-0988219a78fb	100
2000134	vancomycin 50 MG/mL Oral Solution	PSN	8193f588-a032-451e-a0a1-819a5ea834c8	100
2000134	vancomycin 50 MG/ML Oral Solution	SCD	8193f588-a032-451e-a0a1-819a5ea834c8	100
2000134	vancomycin 50 MG/ML Oral Solution	SCD	6c74b360-022a-4c4d-9e4b-0988219a78fb	100
2000134	vancomycin (as vancomycin hydrochloride) 50 MG/ML Oral Solution	SY	8193f588-a032-451e-a0a1-819a5ea834c8	100
2000134	vancomycin (as vancomycin hydrochloride) 50 MG/ML Oral Solution	SY	6c74b360-022a-4c4d-9e4b-0988219a78fb	100
2000134	vancomycin 15 GM per 289 ML Powder for Oral Solution	SY	6c74b360-022a-4c4d-9e4b-0988219a78fb	100
2000134	vancomycin 15 GM per 289 ML Powder for Oral Solution	SY	8193f588-a032-451e-a0a1-819a5ea834c8	100
2000134	vancomycin 250 MG per 5 ML Powder for Oral Solution	SY	8193f588-a032-451e-a0a1-819a5ea834c8	100
2000134	vancomycin 250 MG per 5 ML Powder for Oral Solution	SY	6c74b360-022a-4c4d-9e4b-0988219a78fb	100
2000134	vancomycin 7.5 GM per 145 ML Powder for Oral Solution	SY	8193f588-a032-451e-a0a1-819a5ea834c8	100
2000134	vancomycin 7.5 GM per 145 ML Powder for Oral Solution	SY	6c74b360-022a-4c4d-9e4b-0988219a78fb	100
2000134	vancomycin 50 MG/mL Oral Solution	PSN	27d06545-1af0-4dcd-926d-58d4a9492ec3	3
2000134	vancomycin 50 MG/ML Oral Solution	SCD	27d06545-1af0-4dcd-926d-58d4a9492ec3	3
2000134	vancomycin (as vancomycin hydrochloride) 50 MG/ML Oral Solution	SY	27d06545-1af0-4dcd-926d-58d4a9492ec3	3
2000134	vancomycin 15 GM per 289 ML Powder for Oral Solution	SY	27d06545-1af0-4dcd-926d-58d4a9492ec3	3
2000134	vancomycin 250 MG per 5 ML Powder for Oral Solution	SY	27d06545-1af0-4dcd-926d-58d4a9492ec3	3
2000134	vancomycin 7.5 GM per 145 ML Powder for Oral Solution	SY	27d06545-1af0-4dcd-926d-58d4a9492ec3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62559-830-03	62559083003	300 mL in 1 BOTTLE, PLASTIC (62559-830-03)	300 ml	2019-09-09	0000-00-00	No	No	Current
62559-830-55	62559083055	150 mL in 1 BOTTLE, PLASTIC (62559-830-55)	150 ml	2019-09-09	0000-00-00	No	No	Current
62559-830-80	62559083080	80 mL in 1 BOTTLE, PLASTIC (62559-830-80)	80 ml	2019-09-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vancomycin Hydrochloride for Oral Solution USP Rx only	Bryant Ranch Prepack	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	106
Vancomycin Hydrochloride for Oral Solution USP Rx only	Bryant Ranch Prepack	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	105
Vancomycin Hydrochloride for Oral Solution USP Rx only	Bryant Ranch Prepack	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	105
Vancomycin Hydrochloride for Oral Solution USP Rx only	ANI Pharmaceuticals, Inc.	2026-03-02	HUMAN PRESCRIPTION DRUG LABEL	3
Vancomycin Hydrochloride for Oral Solution USP Rx only	Bryant Ranch Prepack	2025-11-06	HUMAN PRESCRIPTION DRUG LABEL	100
Vancomycin Hydrochloride for Oral Solution USP Rx only	Bryant Ranch Prepack	2025-11-05	HUMAN PRESCRIPTION DRUG LABEL	100
Vancomycin Hydrochloride for Oral Solution USP Rx only	Bryant Ranch Prepack	2025-04-10	HUMAN PRESCRIPTION DRUG LABEL	103

Vancomycin Hydrochloride

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#