vancomycin hydrochloride

Product NDC: 59651-670
Requested package NDC: 59651-670-55
11-digit product format: 596510670
Labeler code: 59651
Product ID: 59651-670_e1008de0-8530-4998-8f8e-7d302e437e4f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vancomycin hydrochloride
Dosage form: KIT
Labeler: Aurobindo Pharma Limited
Application: ANDA218130
Marketing category: ANDA
Marketing start: 2026-08-07
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
A218130-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AA		2026-08-07
A218130-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AA		2026-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218130-001	AA
A218130-002	AA

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	A218130-001	VANCOMYCIN HYDROCHLORIDE	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AA	2026-08-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218130-002	VANCOMYCIN HYDROCHLORIDE	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AA	2026-08-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218130-001	VANCOMYCIN HYDROCHLORIDE	EQ 25MG BASE/ML	FOR SOLUTION / ORAL	AA	2026-08-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218130-002	VANCOMYCIN HYDROCHLORIDE	EQ 50MG BASE/ML	FOR SOLUTION / ORAL	AA	2026-08-07	`caaa826d4ba7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218130-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218130-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218130-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218130-002	AA	1	`caaa826d4ba7…`

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2000127	Internal RxNorm lookup
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
e1008de0-8530-4998-8f8e-7d302e437e4f	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
vancomycin hydrochloride	VANCOMYCIN HYDROCHLORIDE	Aurobindo Pharma Limited	e1008de0-8530-4998-8f8e-7d302e437e4f	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218130 application number: ANDA218130 ndc (package): 59651-670-55 ndc (product): 59651-670 ndc11 (package): 59651067055

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
59651-670-55	59651067055	1 KIT in 1 CARTON (59651-670-55) * 145 mL in 1 BOTTLE * 15 g in 1 BOTTLE * 289 mL in 1 BOTTLE * 7.5 g in 1 BOTTLE	1 kit	2026-08-07	No	No	Current