Vancomycin Hydrochloride

Product NDC: 0143-9357
11-digit product format: 001439357
Labeler code: 0143
Product ID: 0143-9357_431d7445-e798-40a7-a8aa-6a8b1ac5813f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vancomycin Hydrochloride
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA203300
Marketing category: ANDA
Marketing start: 2020-08-11
Substance: VANCOMYCIN HYDROCHLORIDE
Active strength: 1 g/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203300-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			2020-08-11
A203300-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP		2020-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203300-002	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 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-08-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2020-08-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203300-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203300-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION		2020-08-11	`87673890dc5c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203300-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203300-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203300-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203300-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203300-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203300-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203300-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203300-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203300-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203300-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203300-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203300-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203300-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203300-002	AP	1	`8072bd15b7f6…`
2021-03-12 10:30 UTC	2021-03	A203300-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A203300-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203300-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A203300-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203300-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A203300-002	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203300-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203300-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203300-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203300-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203300-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203300-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203300-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203300-002	AP	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203300-002	AP	1	`a50c72e98297…`

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	1 g/1

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
1807513	Internal RxNorm lookup
1807516	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
2f5d3131-8ddc-43a5-91f7-947c531796e7	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
0143-9357-01	Vancomycin Hydrochloride	1 in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	1		5
0143-9357-10	Vancomycin Hydrochloride	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9357-01	EA - Each	0143-9357	4b932046-2cd4-4e98-b531-372ef2274058	1	2022-09-12
0143-9357-10	EA - Each	0143-9357	0ec21d56-69c7-40be-8dec-7f1167c315c6	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9357	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	5	Current NDC, Legacy NDC, 2 package rows	20210605_2f5d3131-8ddc-43a5-91f7-947c531796e7.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 · 1 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.	2f5d3131-8ddc-43a5-91f7-947c531796e7	2021-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203300 application number: ANDA203300 ndc (product): 0143-9357

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
1807513	vancomycin 1 GM Injection	PSN	2f5d3131-8ddc-43a5-91f7-947c531796e7	5
1807516	vancomycin 500 MG Injection	PSN	2f5d3131-8ddc-43a5-91f7-947c531796e7	5
1807513	vancomycin 1000 MG Injection	SCD	2f5d3131-8ddc-43a5-91f7-947c531796e7	5
1807516	vancomycin 500 MG Injection	SCD	2f5d3131-8ddc-43a5-91f7-947c531796e7	5
1807513	vancomycin (as vancomycin HCl) 1 GM Injection	SY	2f5d3131-8ddc-43a5-91f7-947c531796e7	5
1807516	vancomycin (as vancomycin HCl) 500 MG Injection	SY	2f5d3131-8ddc-43a5-91f7-947c531796e7	5
1807513	vancomycin 1 GM Injection	SY	2f5d3131-8ddc-43a5-91f7-947c531796e7	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9357-01	00143935701	1 in 1 VIAL						Historical
0143-9357-10	00143935710	10 VIAL in 1 CARTON (0143-9357-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0143-9357-01)	10 vial	2020-08-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vancomycin Hydrochloride for Injection, USP	Hikma Pharmaceuticals USA Inc.	2021-06-02	HUMAN PRESCRIPTION DRUG LABEL	5