Prescription drug · ANDA
Erythromycin NDC 76420-212
Erythromycin 5 mg/g · Ointment · Ophthalmic · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-212-30 | 7642002123076420021230 | 1 TUBE in 1 CARTON (76420-212-30) / 3.5 g in 1 TUBEMarketed from Mar 8, 2022 |
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
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064030
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
- Identifiers
- Product ID 76420-212_d9ae93e7-f4a8-1df3-e053-2a95a90ae5b1SPL ID d9ae93e7-f4a8-1df3-e053-2a95a90ae5b1SPL set ID bccdb8f3-b5f5-4f07-8ddb-8811d5c1b73cRxCUI 310149UNII 63937KV33D
- 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
N476420021230followed by a unit qualifier and the quantityPackage 76420-0212-30. 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.
About NDC 76420-212
- What is NDC 76420-212?
- 76420-212 is the product NDC for Erythromycin, Erythromycin 5 mg/g ointment, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Erythromycin.
- What is the active ingredient?
- Erythromycin.
- Who is the labeler?
- Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Erythromycin?
- 68 other product NDCs are listed under this name. See all Erythromycin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Erythromycin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | Sentiss Pharmaceuticals LLC | 70244-031 | 70244-0031-0170244-0031-02 |
| Erythromycin | Erythromycin 333 mg/1 | Tablet, Delayed releaseOral | Torrent Pharmaceuticals Limited | 13668-587 | 13668-0587-0113668-0587-0513668-0587-30 |
| erythromycin | Erythromycin 250 mg/1 | Capsule, Delayed release pelletsOral | Dr. Reddy's Labratories Inc. | 75907-076 | 75907-0076-01 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | ST. MARY'S MEDICAL PARK PHARMACY | 60760-670 | 60760-0670-35 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | Redpharm Drug | 67296-2128 | 67296-2128-03 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-3992 | 68071-3992-02 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | ARMAS PHARMACEUTICALS INC. | 72485-670 | 72485-0670-3172485-0670-35 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | Fera Pharmaceuticals, LLC | 48102-057 | 48102-0057-11 |
| Erythromycin | Erythromycin 250 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-397 | 46708-0397-3046708-0397-3146708-0397-91 |
| Erythromycin | Erythromycin 500 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-398 | 46708-0398-3046708-0398-3146708-0398-91 |
Other NDCs under ANDA 064030
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 | ST. MARY'S MEDICAL PARK PHARMACY | 60760-670 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | Proficient Rx LP | 63187-267 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | Redpharm Drug | 67296-2128 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-3992 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | Sentiss Pharmaceuticals LLC | 70244-031 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | ARMAS PHARMACEUTICALS INC. | 72485-670 |