Home NDC 59651-669 vancomycin hydrochloride
Product NDC 59651-669
11-digit product format 596510669
Labeler code 59651
Product ID 59651-669_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.
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 RLD / RS 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# 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-669-03 59651066903 1 KIT in 1 CARTON (59651-669-03) * 147 mL in 1 BOTTLE * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE * 3.75 g in 1 BOTTLE 1 kit 2026-08-07 No No Current 59651-669-55 59651066955 1 KIT in 1 CARTON (59651-669-55) * 147 mL in 1 BOTTLE * 7.5 g in 1 BOTTLE * 295 mL in 1 BOTTLE * 3.75 g in 1 BOTTLE 1 kit 2026-08-07 No No Current