Prescription drug · ANDA
erythromycin NDC 68071-4803
Erythromycin 5 mg/g · Ointment · Ophthalmic · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4803-3 | 68071480303 | 3.5 g in 1 BOX (68071-4803-3)Marketed from Mar 14, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- erythromycin
- Generic name (nonproprietary)
- erythromycin
- Active ingredients
- Erythromycin — 5 mg/g
- Dosage form
- Ointment
- Route
- Ophthalmic
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062447
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
- Identifiers
- Product ID 68071-4803_1adc6bbc-3f85-b36b-e063-6294a90a6c27SPL ID 1adc6bbc-3f85-b36b-e063-6294a90a6c27SPL set ID 84119a8f-78d1-2882-e053-2a91aa0a6faaRxCUI 310149UNII 63937KV33DUPC 0368071480337
- Pharmacologic class
- Macrolide Antimicrobial; Macrolide
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
N468071480303followed by a unit qualifier and the quantityPackage 68071-4803-03. 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)
INDICATIONS AND USAGE: For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin. For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis . The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrheae is not established. For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 062447
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 |
|---|---|---|---|---|
| erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | Asclemed USA, Inc. | 76420-612 |
| erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | A-S Medication Solutions | 50090-1958 |