Prescription drug · ANDA
Erythromycin NDC 46708-398
Erythromycin 500 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-398-30 | 46708039830 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-398-30)Marketed from Aug 28, 2023 | |
| 46708-398-31 | 46708039831 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-398-31)Marketed from Aug 28, 2023 | |
| 46708-398-91 | 46708039891 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-398-91)Marketed from Aug 28, 2023 |
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 — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215661
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
- Identifiers
- Product ID 46708-398_904b9ab6-9a2a-47f3-8a38-04920ce696e0SPL ID 904b9ab6-9a2a-47f3-8a38-04920ce696e0SPL set ID 904b9ab6-9a2a-47f3-8a38-04920ce696e0RxCUI 197650, 598006UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N446708039830followed by a unit qualifier and the quantityPackage 46708-0398-30. 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 To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin tablets and other antibacterial drugs, erythromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Erythromycin tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms …
Excerpt only. Read the full label for complete information.
About NDC 46708-398
- What is NDC 46708-398?
- 46708-398 is the product NDC for Erythromycin, Erythromycin 500 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 package NDCs, 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?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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?
- 69 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 | Redpharm Drug | 67296-2128 | 67296-2128-03 |
| Erythromycin | Erythromycin 5 mg/g | OintmentOphthalmic | ST. MARY'S MEDICAL PARK PHARMACY | 60760-670 | 60760-0670-35 |
| 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 500 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-398 | 62332-0398-3062332-0398-3162332-0398-91 |
| Erythromycin | Erythromycin 250 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-397 | 62332-0397-3062332-0397-3162332-0397-91 |
Other NDCs under ANDA 215661
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 500 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-398 |
| Erythromycin | Erythromycin 250 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-397 |
| Erythromycin | Erythromycin 250 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-397 |