Prescription drug · ANDA
Erythromycin NDC 63187-608
Erythromycin 5 mg/g · Ointment · Ophthalmic · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-608-35 | 63187060835 | 1 TUBE in 1 CARTON (63187-608-35) / 3.5 g in 1 TUBEMarketed from Dec 1, 2018 |
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)
- Erythromycin
- Generic name (nonproprietary)
- erythromycin
- Active ingredients
- Erythromycin — 5 mg/g
- Dosage form
- Ointment
- Route
- Ophthalmic
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064067
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
- Identifiers
- Product ID 63187-608_bb8e6b6b-70fd-48b7-b43d-23180531dc9fSPL ID bb8e6b6b-70fd-48b7-b43d-23180531dc9fSPL set ID 5101bf55-cacf-42bf-8dd1-2a29e80ca6f1RxCUI 310149UNII 63937KV33DUPC 0363187608354
- 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
N463187060835followed by a unit qualifier and the quantityPackage 63187-0608-35. 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. gonorrhoeae 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 064067
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 | REMEDYREPACK INC. | 70518-0465 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | Sportpharm LLC | 85766-248 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | NuCare Pharmaceuticals,Inc. | 66267-975 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | Direct Rx | 61919-090 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | Bausch & Lomb Incorporated | 24208-910 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | Preferred Pharmaceuticals, Inc. | 68788-9328 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | A-S Medication Solutions | 50090-1484 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-4228 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | Asclemed USA, Inc. | 76420-196 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | Cardinal Health 107, LLC | 55154-7850 |