Vancomycin Hydrochloride

Product NDC: 63629-1972
11-digit product format: 636291972
Labeler code: 63629
Product ID: 63629-1972_16157db2-78ce-4fe6-9cc5-33d433db882b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vancomycin Hydrochloride
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA061667
Marketing category: ANDA
Marketing start: 2019-09-09
Substance: VANCOMYCIN HYDROCHLORIDE
Active strength: 250 mg/5mL
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 42.

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
A061667-001	VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982
A061667-002	VANCOCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	RS	1983-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL			1983-07-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061667-001	VANCOCIN HYDROCHLORIDE	EQ 500MG BASE/6ML	FOR SOLUTION / ORAL		Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A061667-002	VANCOCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS	1983-07-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061667-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061667-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061667-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061667-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061667-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061667-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061667-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061667-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061667-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061667-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061667-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061667-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061667-002	AA	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A061667-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A061667-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A061667-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A061667-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A061667-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A061667-002	AA	1	`a67488948f0b…`

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/5mL

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
2000134	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
a09c589b-e7f4-457c-827f-e1bfa1b26700	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
63629-1972-1	Vancomycin Hydrochloride	300 mL in 1 BOTTLE	POWDER, FOR SOLUTION	300		105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-1972-1	ML - Milliliter	63629-1972	2dcfdc25-f24b-4a40-9d31-dde639d1cd76	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-1972	VANCOMYCIN HYDROCHLORIDE POWDER, FOR SOLUTION [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 1 package rows	20230228_a09c589b-e7f4-457c-827f-e1bfa1b26700.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 · 7 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	28fe3c01-cf87-41c0-87fd-f93a40524335	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061667 application number: ANDA061667
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	6c74b360-022a-4c4d-9e4b-0988219a78fb	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061667 application number: ANDA061667
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	8193f588-a032-451e-a0a1-819a5ea834c8	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061667 application number: ANDA061667
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	a09c589b-e7f4-457c-827f-e1bfa1b26700	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061667 application number: ANDA061667 ndc (product): 63629-1972
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	786bde33-9aec-4b4d-ba46-90bfd61956d0	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061667 application number: ANDA061667
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Bryant Ranch Prepack	9b6a7a21-4fde-40c6-a420-a8546a4dc701	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061667 application number: ANDA061667
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	27d06545-1af0-4dcd-926d-58d4a9492ec3	2026-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061667 application number: ANDA061667

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
2000134	vancomycin 50 MG/mL Oral Solution	PSN	a09c589b-e7f4-457c-827f-e1bfa1b26700	105
2000134	vancomycin 50 MG/ML Oral Solution	SCD	a09c589b-e7f4-457c-827f-e1bfa1b26700	105
2000134	vancomycin (as vancomycin hydrochloride) 50 MG/ML Oral Solution	SY	a09c589b-e7f4-457c-827f-e1bfa1b26700	105
2000134	vancomycin 15 GM per 289 ML Powder for Oral Solution	SY	a09c589b-e7f4-457c-827f-e1bfa1b26700	105
2000134	vancomycin 250 MG per 5 ML Powder for Oral Solution	SY	a09c589b-e7f4-457c-827f-e1bfa1b26700	105
2000134	vancomycin 7.5 GM per 145 ML Powder for Oral Solution	SY	a09c589b-e7f4-457c-827f-e1bfa1b26700	105

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1972-1	63629197201	300 mL in 1 BOTTLE (63629-1972-1)	300 ml	2019-09-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vancomycin Hydrochloride for Oral Solution USP Rx only	Bryant Ranch Prepack	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	105