Prescription drug · ANDA
Erythromycin NDC 52536-103
Erythromycin 250 mg/1 · Tablet, Film coated · Oral · Wilshire Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52536-103-03 | 5253601030352536010303 | 30 TABLET, FILM COATED in 1 BOTTLE (52536-103-03)Marketed from Mar 15, 2018 | |
| 52536-103-13 | 5253601031352536010313 | 100 TABLET, FILM COATED in 1 BOTTLE (52536-103-13)Marketed from Mar 15, 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 — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Wilshire PharmaceuticalsNDC labeler code 52536
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 061621
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
- Identifiers
- Product ID 52536-103_f9275e3a-b44f-4839-989c-ee88d44eef46SPL ID f9275e3a-b44f-4839-989c-ee88d44eef46SPL set ID f2efbc94-64f7-4130-ab23-e5983854f730RxCUI 197650, 598006UNII 63937KV33DUPC 0352536103039, 0352536105033
- 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
N452536010303followed by a unit qualifier and the quantityPackage 52536-0103-03. 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 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin Tablets, USP and other antibacterial drugs, Erythromycin Tablets, USP 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, USP are indicated in the treatment of infections caused by susceptible strains of the designated …
Excerpt only. Read the full label for complete information.
About NDC 52536-103
- What is NDC 52536-103?
- 52536-103 is the product NDC for Erythromycin, Erythromycin 250 mg/1 tablet, film coated, listed with the FDA by Wilshire Pharmaceuticals. It has 2 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?
- Wilshire Pharmaceuticals, NDC labeler code 52536. 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 061621
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 250 mg/1 | Tablet, Film coatedOral | Arbor Pharmaceuticals, Inc. | 24338-102 |
| Erythromycin | Erythromycin 500 mg/1 | Tablet, Film coatedOral | Arbor Pharmaceuticals, Inc. | 24338-104 |
| Erythromycin | Erythromycin 500 mg/1 | Tablet, Film coatedOral | Wilshire Pharmaceuticals | 52536-105 |
| Erythromycin | Erythromycin 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 55289-075 |