Vancomycin Hydrochloride

Product NDC: 68462-958
11-digit product format: 684620958
Labeler code: 68462
Product ID: 68462-958_b79d9671-02dd-40e2-97fb-a6c7be85cda1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vancomycin Hydrochloride
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: GLENMARK PHARMACEUTICALS INC., USA
Application: ANDA205694
Marketing category: ANDA
Marketing start: 2026-10-12
Substance: VANCOMYCIN HYDROCHLORIDE
Active strength: 10 g/100mL
Pharmacologic classes: Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205694-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21
A205694-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21
A205694-003	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06
A205694-004	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A205694-001	AP
A205694-002	AP
A205694-003	AP
A205694-004	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 4 · 138 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
2026-10-15 13:18:30	2026-09	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205694-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205694-002	VANCOMYCIN HYDROCHLORIDE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	AP	2016-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205694-003	VANCOMYCIN HYDROCHLORIDE	EQ 5GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205694-004	VANCOMYCIN HYDROCHLORIDE	EQ 10GM BASE/VIAL	INJECTABLE / INJECTION	AP	2023-06-06	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 138 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205694-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205694-002	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205694-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205694-002	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205694-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205694-002	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205694-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205694-002	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205694-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A205694-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205694-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A205694-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205694-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A205694-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205694-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205694-002	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205694-003	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205694-004	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205694-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205694-002	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205694-003	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205694-004	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205694-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205694-002	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205694-003	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205694-004	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205694-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205694-002	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205694-003	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205694-004	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205694-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205694-002	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205694-003	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205694-004	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205694-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205694-002	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205694-003	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205694-004	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205694-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205694-002	AP	1	`3f0d92c62455…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VANCOMYCIN HYDROCHLORIDE	10 g/100mL

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 · 5 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	74056e26-57fd-448e-af76-edbccfc3efb7	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205694 application number: ANDA205694
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Gland Pharma Limited	00946db3-d6c5-4534-a870-1ec6e63eda43	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205694 application number: ANDA205694
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Xellia Pharmaceuticals USA LLC	8403695c-3614-490b-9797-6c5ebcdeef9b	2023-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205694 application number: ANDA205694
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Gland Pharma Limited	35ecffbc-77d8-4c0d-9b14-6a3cc442dec6	2023-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205694 application number: ANDA205694
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Sagent Pharmaceuticals	4843726f-6e79-6e20-2620-4a54616e6479	2023-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205694 application number: ANDA205694

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
71WO621TJD	VANCOMYCIN HYDROCHLORIDE	1404-93-9	VANCOMYCIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68462-958-10	68462095810	1 BOTTLE in 1 CARTON (68462-958-10) / 100 mL in 1 BOTTLE	1 bottle	2026-10-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vancomycin Hydrochloride	GLENMARK PHARMACEUTICALS INC., USA \| Gland Pharma Limited	2026-10-08	HUMAN PRESCRIPTION DRUG LABEL	1