Vancomycin Hydrochloride

Product NDC: 69238-2261
Requested package NDC: 69238-2261-3
11-digit product format: 692382261
Labeler code: 69238
Product ID: 69238-2261_71d25621-053b-45e0-a795-60d19aa5effa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vancomycin Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA215338
Marketing category: ANDA
Marketing start: 2023-06-26
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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215338-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL			2023-06-23

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.

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	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		2023-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		2023-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		2023-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL	AA	2023-06-23	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215338-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		2023-06-23	`a50c72e98297…`

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	A215338-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215338-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215338-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215338-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215338-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215338-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215338-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215338-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215338-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215338-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215338-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215338-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215338-001	AA	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215338-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215338-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215338-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215338-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215338-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215338-001	AA	1	`a67488948f0b…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A215338-001	CGT	2023-12-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215338-001	CGT	2023-12-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215338-001	CGT	2023-12-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215338-001	CGT	2023-12-20	`a67488948f0b…`

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/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
3c47d5c4-8cdb-4701-8d7a-8a6e79025b53	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	SPL version
69238-2261-3	Vancomycin Hydrochloride	80 mL in 1 BOTTLE	SOLUTION	80	4
69238-2261-5	Vancomycin Hydrochloride	300 mL in 1 BOTTLE	SOLUTION	300	4
69238-2261-7	Vancomycin Hydrochloride	150 mL in 1 BOTTLE	SOLUTION	150	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-2261-3	ML - Milliliter	69238-2261	683fc41f-c502-4717-be32-00b94c282e7a	1	2023-07-06
69238-2261-5	ML - Milliliter	69238-2261	415b0c5e-9677-43e8-9792-7105be92aca4	1	2023-07-06
69238-2261-7	ML - Milliliter	69238-2261	fda07cf1-6491-4b54-b33e-c06b5ea8143d	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-2261	VANCOMYCIN HYDROCHLORIDE SOLUTION [AMNEAL PHARMACEUTICALS NY LLC]	3	Current NDC, 3 package rows	20230627_3c47d5c4-8cdb-4701-8d7a-8a6e79025b53.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	3c47d5c4-8cdb-4701-8d7a-8a6e79025b53	2023-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215338 application number: ANDA215338 ndc (package): 69238-2261-3 ndc (product): 69238-2261 ndc11 (package): 69238226103

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	3c47d5c4-8cdb-4701-8d7a-8a6e79025b53	4
2000134	vancomycin 50 MG/ML Oral Solution	SCD	3c47d5c4-8cdb-4701-8d7a-8a6e79025b53	4
2000134	vancomycin (as vancomycin hydrochloride) 50 MG/ML Oral Solution	SY	3c47d5c4-8cdb-4701-8d7a-8a6e79025b53	4
2000134	vancomycin 15 GM per 289 ML Powder for Oral Solution	SY	3c47d5c4-8cdb-4701-8d7a-8a6e79025b53	4
2000134	vancomycin 250 MG per 5 ML Powder for Oral Solution	SY	3c47d5c4-8cdb-4701-8d7a-8a6e79025b53	4
2000134	vancomycin 7.5 GM per 145 ML Powder for Oral Solution	SY	3c47d5c4-8cdb-4701-8d7a-8a6e79025b53	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69238-2261-3	69238226103	80 mL in 1 BOTTLE (69238-2261-3)	80 ml	2023-06-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vancomycin Hydrochloride for Oral Solution, USP	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals, LLC	2023-06-23	HUMAN PRESCRIPTION DRUG LABEL	4