Prescription drug · ANDA
Gentamicin Sulfate NDC 61314-633
Gentamicin sulfate 3 mg/mL · Solution · Ophthalmic · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61314-633-05 | 6131406330561314063305 | 1 BOTTLE, DROPPER in 1 CARTON (61314-633-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Apr 5, 1996 |
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)
- Gentamicin Sulfate
- Generic name (nonproprietary)
- gentamicin sulfate
- Active ingredients
- Gentamicin sulfate — 3 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Sandoz IncNDC labeler code 61314
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062196
- Marketing start
- Listing expires
- Other FDA classes
- Aminoglycosides (Chemical structure)
- Identifiers
- Product ID 61314-633_a628d79b-79de-49ec-b116-c605ba0fb991SPL ID a628d79b-79de-49ec-b116-c605ba0fb991SPL set ID a213fb9c-08ea-4f30-a6c9-93c7a9ba5280RxCUI 310467UNII 8X7386QRLV
- Pharmacologic class
- Aminoglycoside Antibacterial
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 HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N461314063305followed by a unit qualifier and the quantityPackage 61314-0633-05. 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)
INDICATIONS AND USAGE Gentamicin Sulfate Ophthalmic Solution is indicated in the topical treatment of ocular bacterial infections, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
Excerpt only. Read the full label for complete information.
About NDC 61314-633
- What is NDC 61314-633?
- 61314-633 is the product NDC for Gentamicin Sulfate, Gentamicin sulfate 3 mg/mL solution, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gentamicin Sulfate.
- What is the active ingredient?
- Gentamicin sulfate.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 61314. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gentamicin Sulfate?
- 25 other product NDCs are listed under this name. See all Gentamicin Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gentamicin Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gentamicin Sulfate | Gentamicin sulfate 1 mg/g | OintmentTopical | Encube Ethicals, Inc. | 21922-110 | 21922-0110-0421922-0110-05 |
| Gentamicin Sulfate | Gentamicin sulfate 3 mg/mL | Solution/ dropsOphthalmic | Preferred Pharmaceuticals Inc. | 68788-8592 | 68788-8592-05 |
| Gentamicin Sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1597 | 51662-1597-03 |
| Gentamicin Sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9865 | 00404-9865-02 |
| Gentamicin Sulfate | Gentamicin sulfate 1 mg/g | CreamTopical | Cosette Pharmaceuticals, Inc. | 0713-0683 | 00713-0683-1500713-0683-31 |
| Gentamicin Sulfate | Gentamicin sulfate 40 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7216 | 71872-7216-01 |
| Gentamicin Sulfate | Gentamicin sulfate 1 mg/g | OintmentTopical | Cosette Pharmaceuticals, Inc. | 0713-0682 | 00713-0682-1500713-0682-31 |
| Gentamicin Sulfate | Gentamicin sulfate 1 mg/g | OintmentTopical | Proficient Rx LP | 71205-560 | 71205-0560-15 |
| gentamicin sulfate | Gentamicin sulfate 3 mg/mL | Solution/ dropsOphthalmic | DIRECT RX | 61919-106 | 61919-0106-05 |
| Gentamicin Sulfate | Gentamicin sulfate 3 mg/mL | Solution/ dropsOphthalmic | Proficient Rx LP | 63187-764 | 63187-0764-05 |
Other NDCs under ANDA 062196
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 |
|---|---|---|---|---|
| Gentamicin Sulfate | Gentamicin sulfate 3 mg/mL | SolutionOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4775 |
| Gentamicin Sulfate | Gentamicin sulfate 3 mg/mL | SolutionOphthalmic | Proficient Rx LP | 71205-333 |
| Gentamicin Sulfate | Gentamicin sulfate 3 mg/mL | SolutionOphthalmic | Asclemed USA, Inc. | 76420-137 |