vancomycin hydrochloride

Product NDC: 67296-2290
11-digit product format: 672962290
Labeler code: 67296
Product ID: 67296-2290_57d23aed-a3f8-f92e-e063-6394a90add7d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vancomycin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA065490
Marketing category: ANDA
Marketing start: 2026-01-01
Substance: VANCOMYCIN HYDROCHLORIDE
Active strength: 125 mg/1
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 43.

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
A065490-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB		2012-04-09
A065490-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB		2012-04-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A065490-001	AB
A065490-002	AB

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 3 · 86 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
2026-09-14 22:38:34	2026-08	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065490-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2012-04-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065490-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2012-04-09	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065490-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065490-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065490-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065490-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065490-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065490-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065490-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065490-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065490-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065490-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065490-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065490-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065490-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065490-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065490-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065490-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065490-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065490-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065490-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065490-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065490-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065490-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065490-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065490-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065490-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065490-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065490-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065490-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065490-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065490-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065490-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065490-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065490-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065490-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065490-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065490-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065490-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065490-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065490-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065490-002	AB	1	`74a2ff9319b5…`

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	125 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313570	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
57d23aed-a3f7-f92e-e063-6394a90add7d	Available on FDA.report

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	Redpharm Drug	57d23aed-a3f7-f92e-e063-6394a90add7d	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065490 application number: ANDA065490 ndc (product): 67296-2290
vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ab658fbd-68ea-4275-84b1-c3361c860bd3	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065490 application number: ANDA065490
vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	Strides Pharma Science Limited	fac438bd-e08f-438d-ab64-426fc5c5450e	2025-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065490 application number: ANDA065490

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
67296-2290-4	67296229004	40 CAPSULE in 1 BOTTLE (67296-2290-4)	40 capsule	2026-01-01	No	No	Current