VANCOMYCIN HYDROCHLORIDE

Product NDC: 0121-0867
Requested package NDC: 0121-0867-20
11-digit product format: 001210867
Labeler code: 0121
Product ID: 0121-0867_46c61b28-1b3a-4f06-bcba-bf1fba0a6287
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VANCOMYCIN HYDROCHLORIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: PAI Holdings, LLC
Application: ANDA210729
Marketing category: ANDA
Marketing start: 2019-07-25
Marketing end: 0000-00-00
Substance: VANCOMYCIN HYDROCHLORIDE
Active strength: 125 mg/1
Pharmacologic classes: Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag: No
Listing certified through: 2024-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0121-0867	0121-0867-20	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0121-0867	0121-0867-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0121-0867	0121-0867-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0121-0867	0121-0867-20	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`

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
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 · 82 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	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…`
2022-03-09 01:35 UTC	2022-03	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210729-001	VANCOMYCIN HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL	AB	2019-04-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210729-002	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE	CAPSULE / ORAL	AB	2019-04-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-03-09 01:35 UTC	2022-03	A210729-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210729-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210729-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210729-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0867-20	EA - Each	0121-0867	a5d2f528-b260-4d10-98a0-8adc5011f3bb	1	2019-09-05
0121-0867-50	EA - Each	0121-0867	15719040-3264-465b-81d3-6fbcf3c86efc	1	2020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0867	VANCOMYCIN HYDROCHLORIDE CAPSULE [PAI HOLDINGS, LLC DBA PAI PHARMA]	13	Legacy NDC	20250316_8eacc01c-5ce6-1869-e053-2a95a90a57ce.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	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
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Cameron Pharmaceuticals	bc737938-ae36-460b-a2a8-609f3fe59156	2026-04-14	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	Marketing end	Sample	Exclude flag	Status
0121-0867-20	00121086720	2 BLISTER PACK in 1 CARTON (0121-0867-20) > 10 CAPSULE in 1 BLISTER PACK	2 blister pack	2019-07-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VANCOMYCIN HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	2025-02-25	HUMAN PRESCRIPTION DRUG LABEL	13
VANCOMYCIN HYDROCHLORIDE	REMEDYREPACK INC.	2024-03-26	HUMAN PRESCRIPTION DRUG LABEL	2
VANCOMYCIN HYDROCHLORIDE	PAI Holdings, LLC	2023-01-11	HUMAN PRESCRIPTION DRUG LABEL	5