Prescription drug · NDA
Erythromycin Ethylsuccinate NDC 52536-134
Erythromycin ethylsuccinate 200 mg/5mL · Granule, For suspension · Oral · Wilshire Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52536-134-13 | 5253601341352536013413 | 100 mL in 1 BOTTLE (52536-134-13)Marketed from Sep 28, 2016 |
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 Ethylsuccinate
- Generic name (nonproprietary)
- erythromycin ethylsuccinate
- Active ingredients
- Erythromycin ethylsuccinate — 200 mg/5mL
- Dosage form
- Granule, For suspension
- Route
- Oral
- Labeler
- Wilshire Pharmaceuticals Inc.NDC labeler code 52536
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050207
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
- Identifiers
- Product ID 52536-134_98a85646-cc9b-429f-9b46-4a3ce1b5c129SPL ID 98a85646-cc9b-429f-9b46-4a3ce1b5c129SPL set ID f4a3fffd-ce02-450f-bbcc-d425374e3e32RxCUI 686400UNII 1014KSJ86FUPC 0300746302131
- 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
N452536013413followed by a unit qualifier and the quantityPackage 52536-0134-13. 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 Ethylsuccinate and other antibacterial drugs, Erythromycin Ethylsuccinate 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 Ethylsuccinate is indicated in the treatment of infections caused by susceptible strains of the design…
Excerpt only. Read the full label for complete information.
About NDC 52536-134
- What is NDC 52536-134?
- 52536-134 is the product NDC for Erythromycin Ethylsuccinate, Erythromycin ethylsuccinate 200 mg/5mL granule, for suspension, listed with the FDA by Wilshire Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Erythromycin Ethylsuccinate.
- What is the active ingredient?
- Erythromycin ethylsuccinate.
- Who is the labeler?
- Wilshire Pharmaceuticals Inc., 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 Ethylsuccinate?
- 19 other product NDCs are listed under this name. See all Erythromycin Ethylsuccinate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Erythromycin Ethylsuccinate 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 Ethylsuccinateerythromycin | Erythromycin ethylsuccinate 200 mg/5mL | SuspensionOral | Amneal Pharmaceuticals NY LLC | 60219-1503 | 60219-1503-01 |
| Erythromycin Ethylsuccinateerythromycin | Erythromycin ethylsuccinate 400 mg/5mL | SuspensionOral | Amneal Pharmaceuticals NY LLC | 60219-1504 | 60219-1504-02 |
| Erythromycin Ethylsuccinate | Erythromycin ethylsuccinate 400 mg/5mL | SuspensionOral | Nivagen Pharmaceuticals, Inc. | 75834-294 | 75834-0294-01 |
| Erythromycin Ethylsuccinate | Erythromycin ethylsuccinate 200 mg/5mL | SuspensionOral | Nivagen Pharmaceuticals, Inc. | 75834-295 | 75834-0295-01 |
| Erythromycin ethylsuccinate | Erythromycin ethylsuccinate 200 mg/5mL | For suspensionOral | Cadila Pharmaceuticals Limited | 71209-102 | 71209-0102-21 |
| Erythromycin ethylsuccinate | Erythromycin ethylsuccinate 400 mg/5mL | For suspensionOral | Cadila Pharmaceuticals Limited | 71209-103 | 71209-0103-21 |
| Erythromycin ethylsuccinate | Erythromycin ethylsuccinate 200 mg/5mL | For suspensionOral | Bryant Ranch Prepack | 72162-2657 | 72162-2657-01 |
| Erythromycin ethylsuccinate | Erythromycin ethylsuccinate 400 mg/5mL | For suspensionOral | Bryant Ranch Prepack | 72162-2658 | 72162-2658-01 |
| Erythromycin ethylsuccinate | Erythromycin ethylsuccinate 200 mg/5mL | For suspensionOral | Kanchan Healthcare Inc | 85742-029 | 85742-0029-28 |
| Erythromycin ethylsuccinate | Erythromycin ethylsuccinate 400 mg/5mL | For suspensionOral | Kanchan Healthcare Inc | 85742-030 | 85742-0030-28 |
Other NDCs under NDA 050207
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 |
|---|---|---|---|---|
| E.E.Serythromycin ethylsuccinate | Erythromycin ethylsuccinate 200 mg/5mL | Granule, For suspensionOral | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 24338-134 |
| E.E.Serythromycin ethylsuccinate | Erythromycin ethylsuccinate 200 mg/5mL | Granule, For suspensionOral | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 24338-136 |
| Ery-Pederythromycin ethylsuccinate | Erythromycin ethylsuccinate 400 mg/5mL | SuspensionOral | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 24338-130 |
| Ery-Pederythromycin ethylsuccinate | Erythromycin ethylsuccinate 200 mg/5mL | SuspensionOral | Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals) | 24338-132 |
| Erythromycin Ethylsuccinate | Erythromycin ethylsuccinate 400 mg/5mL | SuspensionOral | Wilshire Pharmaceuticals | 52536-130 |
| Erythromycin Ethylsuccinate | Erythromycin ethylsuccinate 200 mg/5mL | SuspensionOral | Wilshire Pharmaceuticals | 52536-132 |
| Erythromycin Ethylsuccinate | Erythromycin ethylsuccinate 200 mg/5mL | Granule, For suspensionOral | Wilshire Pharmaceuticals Inc. | 52536-136 |