Prescription drug · ANDA
vancomycin hydrochloride NDC 59651-669
Kit · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 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 BOTTLEMarketed from Aug 7, 2026 | |
| 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 BOTTLEMarketed from Aug 7, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- vancomycin hydrochloride
- Generic name (nonproprietary)
- vancomycin hydrochloride
- Dosage form
- Kit
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218130
- Marketing start
- Listing expires
- Identifiers
- Product ID 59651-669_e1008de0-8530-4998-8f8e-7d302e437e4fSPL ID e1008de0-8530-4998-8f8e-7d302e437e4fSPL set ID e1008de0-8530-4998-8f8e-7d302e437e4fRxCUI 2000127, 2000134UPC 0359651749555, 0359651746172
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N459651066903followed by a unit qualifier and the quantityPackage 59651-0669-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Vancomycin hydrochloride for oral solution is indicated for the treatment of Clostridium difficil e-associated diarrhea in adults and pediatric patients less than 18 years of age. Vancomycin hydrochloride for oral solution is also indicated for the treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adults and pediatric patients less than 18 years of age. Important Limitations of Use Parenteral administration of vancomycin is not effective for the above infections; therefore, vancomycin must be given orally for these infections. Orally administered vancomycin hydrochloride is not effective for treatment of other types of infections. To redu…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218130
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| vancomycin hydrochloride | — | Kit | Aurobindo Pharma Limited | 59651-670 |