Prescription drug · ANDA
Erythromycin and Benzoyl Peroxide NDC 64980-328
Erythromycin 30 mg/g; Benzoyl peroxide 50 mg/g · Gel · Topical · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-328-01 | 6498003280164980032801 | 23.3 g in 1 JAR (64980-328-01)Marketed from Oct 18, 2016 | |
| 64980-328-02 | 6498003280264980032802 | 46.6 g in 1 JAR (64980-328-02)Marketed from Oct 18, 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 and Benzoyl Peroxide
- Generic name (nonproprietary)
- erythromycin and benzoyl peroxide
- Active ingredients
- Erythromycin — 30 mg/gBenzoyl peroxide — 50 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 64980
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065385
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Macrolides (Chemical structure)
- Identifiers
- Product ID 64980-328_8547932c-ed72-4e13-b8fe-2b78919399d5SPL ID 8547932c-ed72-4e13-b8fe-2b78919399d5SPL set ID d449d7e2-5c25-406d-87ab-30809d292476RxCUI 244374UNII 63937KV33D, W9WZN9A0GM
- 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N464980032801followed by a unit qualifier and the quantityPackage 64980-0328-01. 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 Erythromycin and Benzoyl Peroxide Topical Gel USP is indicated for the topical treatment of acne vulgaris.
Excerpt only. Read the full label for complete information.
About NDC 64980-328
- What is NDC 64980-328?
- 64980-328 is the product NDC for Erythromycin and Benzoyl Peroxide, Erythromycin 30 mg/g; Benzoyl peroxide 50 mg/g gel, listed with the FDA by Rising Pharma Holdings, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Erythromycin and Benzoyl Peroxide.
- What is the active ingredient?
- Erythromycin, Benzoyl peroxide.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 64980. 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 and Benzoyl Peroxide?
- 2 other product NDCs are listed under this name. See all Erythromycin and Benzoyl Peroxide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Erythromycin and Benzoyl Peroxide 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 and Benzoyl Peroxide | — | Kit | Oceanside Pharmaceuticals | 68682-900 | 68682-0900-23 |
| Erythromycin and Benzoyl Peroxide | — | Kit | Oceanside Pharmaceuticals | 68682-901 | 68682-0901-46 |