Vancomycin Hydrochloride

Product NDC: 63323-295
11-digit product format: 633230295
Labeler code: 63323
Product ID: 63323-295_020618ad-8f1f-4189-a95c-254f05a077cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VANCOMYCIN HYDROCHLORIDE
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Fresenius Kabi USA, LLC
Application: ANDA062663
Marketing category: ANDA
Marketing start: 2001-07-17
Substance: VANCOMYCIN HYDROCHLORIDE
Active strength: 5 g/100mL
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 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062663-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-03-17
A062663-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-07-31
A062663-003	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-06-03
A062663-004	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1997-11-28
A062663-005	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP		2016-08-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A062663-001	AP
A062663-002	AP
A062663-003	AP
A062663-004	AP
A062663-005	AP

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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062663-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062663-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062663-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062663-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1997-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062663-005	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP		2016-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062663-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062663-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062663-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062663-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1997-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062663-005	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP		2016-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062663-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062663-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062663-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062663-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1997-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062663-005	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP		2016-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062663-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062663-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062663-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062663-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1997-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062663-005	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP		2016-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062663-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-03-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062663-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062663-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062663-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1997-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062663-005	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP		2016-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062663-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-03-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062663-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062663-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062663-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1997-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062663-005	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP		2016-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062663-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-03-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062663-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062663-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062663-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1997-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062663-005	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP		2016-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062663-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-03-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062663-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1987-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062663-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062663-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1997-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062663-005	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	INJECTABLE / INJECTION	AP		2016-08-17	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062663-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062663-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062663-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062663-004	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062663-005	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062663-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062663-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062663-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062663-004	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062663-005	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062663-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062663-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062663-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062663-004	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062663-005	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062663-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062663-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062663-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062663-004	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062663-005	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062663-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062663-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062663-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062663-004	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062663-005	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062663-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062663-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062663-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062663-004	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062663-005	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062663-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062663-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062663-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062663-004	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062663-005	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062663-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062663-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062663-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062663-004	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062663-005	AP	1	`5bbf6a4d5a75…`

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 g/100mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
239209	Internal RxNorm lookup
313572	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
0713a847-a334-4b73-af22-343aa06621b9	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	SPL version
63323-295-61	Vancomycin Hydrochloride	100 mL in 1 BOTTLE	INJECTION, POWDER, LYOPHILIZED,	100	7
63323-295-61	Vancomycin Hydrochloride	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1	7
63323-295-66	Vancomycin Hydrochloride	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1	6
63323-295-66	Vancomycin Hydrochloride	100 mL in 1 BOTTLE	INJECTION, POWDER, LYOPHILIZED,	100	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63323-295-61	EA - Each	63323-295	0a6f4f47-a061-4352-b0ba-e74067c99f20	1	2013-02-13
63323-295-66	EA - Each	63323-295	507c808e-062c-407d-b802-997f390e44bc	1	2015-09-10

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 [FRESENIUS KABI USA, LLC]	1
VANCOMYCIN HYDROCHLORIDE	ACTIVE INGREDIENT	71WO621TJD	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]	1
VANCOMYCIN	ACTIVE MOIETY	6Q205EH1VU	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]	1
VANCOMYCIN	ACTIVE MOIETY	6Q205EH1VU	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APP PHARMACEUTICALS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63323-295	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]	7	Current NDC, Legacy NDC, 2 package rows	20211007_d3147f2d-1a72-4923-874b-8fdee2be625e.zip
63323-295	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]	6	Current NDC, Legacy NDC, 2 package rows	20230316_0713a847-a334-4b73-af22-343aa06621b9.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	f604d399-fded-4f4f-8efe-af558ed07b9d	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062663 application number: ANDA062663
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	9bfe30f8-c662-4af3-bc82-f0102eef8952	2025-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062663 application number: ANDA062663
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	83ea3faf-fedd-4725-911f-d71a23ec5d5e	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062663 application number: ANDA062663
VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	0576803d-95de-4a48-806a-69ae3fcaf6b0	2023-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062663 application number: ANDA062663
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	0713a847-a334-4b73-af22-343aa06621b9	2023-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062663 application number: ANDA062663 ndc (product): 63323-295
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	d3147f2d-1a72-4923-874b-8fdee2be625e	2021-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062663 application number: ANDA062663 ndc (product): 63323-295

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	d3147f2d-1a72-4923-874b-8fdee2be625e	7
313572	vancomycin 50 MG/ML Injectable Solution	PSN	d3147f2d-1a72-4923-874b-8fdee2be625e	7
239209	vancomycin 100 MG/ML Injectable Solution	SCD	d3147f2d-1a72-4923-874b-8fdee2be625e	7
313572	vancomycin 50 MG/ML Injectable Solution	SCD	d3147f2d-1a72-4923-874b-8fdee2be625e	7
239209	vancomycin (as vancomycin hydrochloride) 100 MG/ML Injectable Solution	SY	d3147f2d-1a72-4923-874b-8fdee2be625e	7
313572	vancomycin (as vancomycin hydrochloride) 50 MG/ML Injectable Solution	SY	d3147f2d-1a72-4923-874b-8fdee2be625e	7
239209	vancomycin 100 MG/ML Injectable Solution	PSN	0713a847-a334-4b73-af22-343aa06621b9	6
313572	vancomycin 50 MG/ML Injectable Solution	PSN	0713a847-a334-4b73-af22-343aa06621b9	6
239209	vancomycin 100 MG/ML Injectable Solution	SCD	0713a847-a334-4b73-af22-343aa06621b9	6
313572	vancomycin 50 MG/ML Injectable Solution	SCD	0713a847-a334-4b73-af22-343aa06621b9	6
239209	vancomycin (as vancomycin hydrochloride) 100 MG/ML Injectable Solution	SY	0713a847-a334-4b73-af22-343aa06621b9	6
313572	vancomycin (as vancomycin hydrochloride) 50 MG/ML Injectable Solution	SY	0713a847-a334-4b73-af22-343aa06621b9	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63323-295-61	63323029561	1 BOTTLE in 1 CARTON (63323-295-61) / 100 mL in 1 BOTTLE	1 bottle	2001-07-17	0000-00-00	No	No	Current
63323-295-66	63323029566	1 BOTTLE in 1 CARTON (63323-295-66) / 100 mL in 1 BOTTLE	1 bottle	2001-07-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vancomycin Hydrochloride	Fresenius Kabi USA, LLC	2023-02-07	HUMAN PRESCRIPTION DRUG LABEL	6
Vancomycin Hydrochloride - Fresenius Kabi USA, LLC	Fresenius Kabi USA, LLC	2021-09-30	HUMAN PRESCRIPTION DRUG LABEL	7