vancomycin hydrochloride

Product NDC: 23155-968
11-digit product format: 231550968
Labeler code: 23155
Product ID: 23155-968_ad9b2ab1-1df4-49d4-853b-25437a042039
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vancomycin hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application: ANDA210729
Marketing category: ANDA
Marketing start: 2026-08-10
Substance: VANCOMYCIN HYDROCHLORIDE
Active strength: 250 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
A210729-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB		2019-04-29
A210729-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB		2019-04-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210729-001	AB
A210729-002	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	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`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	A210729-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210729-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210729-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210729-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210729-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210729-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210729-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210729-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210729-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210729-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210729-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210729-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210729-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210729-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210729-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210729-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210729-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210729-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210729-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210729-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210729-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210729-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210729-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210729-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210729-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210729-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210729-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210729-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210729-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210729-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210729-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210729-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210729-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210729-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210729-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210729-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210729-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210729-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210729-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210729-002	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	250 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313570	Internal RxNorm lookup
313571	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
127d95d1-8070-41ac-8343-3168b0cf1312	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Cameron Pharmaceuticals	bc737938-ae36-460b-a2a8-609f3fe59156	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210729 application number: ANDA210729
vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	127d95d1-8070-41ac-8343-3168b0cf1312	2026-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210729 application number: ANDA210729 ndc (product): 23155-968
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	7bbd2c81-33d9-4397-8795-8b9fa28cb5cf	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210729 application number: ANDA210729
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	d6b8147b-5f93-49ee-8b27-78fe58987c90	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210729 application number: ANDA210729

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
23155-968-25	23155096825	50 CAPSULE in 1 BOTTLE (23155-968-25)	50 capsule	2026-08-10	No	No	Current
23155-968-78	23155096878	2 BLISTER PACK in 1 CARTON (23155-968-78) / 10 CAPSULE in 1 BLISTER PACK	2 blister pack	2026-08-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
vancomycin hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. \| Orient Pharma Co.,Ltd Yunlin Plant \| Orient Pharma Co., Ltd. Yunlin Plant	2026-08-05	HUMAN PRESCRIPTION DRUG LABEL	1