Prescription drug · ANDA
Erythromycin NDC 69238-1472
Erythromycin 333 mg/1 · Tablet, Delayed release · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1472-1 | 69238147201 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1472-1)Marketed from Jul 7, 2019 | |
| 69238-1472-3 | 69238147203 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (69238-1472-3)Marketed from Aug 27, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 333 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals NY LLCNDC labeler code 69238
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210954
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
- Identifiers
- Product ID 69238-1472_ecd62575-1fd6-4ed0-ba18-048be51a607cSPL ID ecd62575-1fd6-4ed0-ba18-048be51a607cSPL set ID bb641ed4-8093-4e15-9cb9-8921b1093d50RxCUI 310155, 310157, 315090UNII 63937KV33DUPC 0369238147339, 0369238147230, 0369238147117, 0369238147315, 0369238147216
- 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
N469238147201followed by a unit qualifier and the quantityPackage 69238-1472-01. 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 delayed-release tablets and other antibacterial drugs, erythromycin delayed-release 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 delayed-release tablets are indicated in the treatment of infections caused by susce…
Excerpt only. Read the full label for complete information.
About NDC 69238-1472
- What is NDC 69238-1472?
- 69238-1472 is the product NDC for Erythromycin, Erythromycin 333 mg/1 tablet, delayed release, listed with the FDA by Amneal Pharmaceuticals NY LLC. 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?
- Amneal Pharmaceuticals NY LLC, NDC labeler code 69238. 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 210954
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, Delayed releaseOral | Amneal Pharmaceuticals NY LLC | 69238-1471 |
| Erythromycin | Erythromycin 500 mg/1 | Tablet, Delayed releaseOral | Amneal Pharmaceuticals NY LLC | 69238-1473 |