Vancomycin Hydrochloride

Product NDC: 68083-595
Requested package NDC: 68083-595-10
11-digit product format: 680830595
Labeler code: 68083
Product ID: 68083-595_16f3240c-d1ce-4407-ad09-565915a13805
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vancomycin Hydrochloride
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Gland Pharma Limited
Application: ANDA218140
Marketing category: ANDA
Marketing start: 2025-03-21
Substance: VANCOMYCIN HYDROCHLORIDE
Active strength: 750 mg/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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A218140-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21
A218140-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21
A218140-003	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A218140-001	AP
A218140-002	AP
A218140-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A218140-001	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218140-002	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218140-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218140-001	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218140-002	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218140-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218140-001	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218140-002	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218140-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218140-001	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218140-002	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218140-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218140-001	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218140-002	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218140-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218140-001	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218140-002	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218140-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-03-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218140-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218140-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218140-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218140-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218140-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218140-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218140-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218140-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218140-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218140-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218140-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218140-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218140-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218140-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218140-003	AP	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218140-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218140-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218140-003	AP	1	`a50c72e98297…`

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	750 mg/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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1807518	Internal RxNorm lookup
2049888	Internal RxNorm lookup
2049890	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
65e5f2ee-934c-40d7-967c-00d085f84ffd	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
68083-595-01	Vancomycin Hydrochloride	1 in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1		4
68083-595-10	Vancomycin Hydrochloride	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-595	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED]	4	Current NDC, 2 package rows	20250515_65e5f2ee-934c-40d7-967c-00d085f84ffd.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	GLENMARK PHARMACEUTICALS INC., USA	0543b2b5-b1c7-4ad6-b38c-3be0086f0e06	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218140 application number: ANDA218140
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Sagent Pharmaceuticals	f623889c-a47a-4b3a-b3a9-e04051f5c2df	2025-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218140 application number: ANDA218140
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Gland Pharma Limited	65e5f2ee-934c-40d7-967c-00d085f84ffd	2025-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218140 application number: ANDA218140 ndc (package): 68083-595-10 ndc (product): 68083-595 ndc11 (package): 68083059510

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
2049888	vancomycin 1.25 GM Injection	PSN	65e5f2ee-934c-40d7-967c-00d085f84ffd	4
2049890	vancomycin 1.5 GM Injection	PSN	65e5f2ee-934c-40d7-967c-00d085f84ffd	4
1807518	vancomycin 750 MG Injection	PSN	65e5f2ee-934c-40d7-967c-00d085f84ffd	4
2049888	vancomycin 1250 MG Injection	SCD	65e5f2ee-934c-40d7-967c-00d085f84ffd	4
2049890	vancomycin 1500 MG Injection	SCD	65e5f2ee-934c-40d7-967c-00d085f84ffd	4
1807518	vancomycin 750 MG Injection	SCD	65e5f2ee-934c-40d7-967c-00d085f84ffd	4
2049888	vancomycin 1.25 GM (as vancomycin hydrochloride 1.28 GM) Injection	SY	65e5f2ee-934c-40d7-967c-00d085f84ffd	4
2049888	vancomycin 1.25 GM Injection	SY	65e5f2ee-934c-40d7-967c-00d085f84ffd	4
2049890	vancomycin 1.5 GM (as vancomycin hydrochloride 1.54 GM) Injection	SY	65e5f2ee-934c-40d7-967c-00d085f84ffd	4
2049890	vancomycin 1.5 GM Injection	SY	65e5f2ee-934c-40d7-967c-00d085f84ffd	4
1807518	vancomycin 750 MG (as vancomycin hydrochloride 769 MG) Injection	SY	65e5f2ee-934c-40d7-967c-00d085f84ffd	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68083-595-10	68083059510	10 VIAL, SINGLE-DOSE in 1 CARTON (68083-595-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-595-01)	2025-03-21	No	No	Current