Prescription drug · UNAPPROVED DRUG OTHER
OVACE Plus (Sulfacetamide sodium) NDC 0178-0485
Sulfacetamide sodium 100 mg/mL · Shampoo · Topical · Mission Pharmacal Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0178-0485-04 | 0017804850400178048504 | 10 TUBE in 1 CARTON (0178-0485-04) / 4 mL in 1 TUBEMarketed from Sep 15, 2011 · Sample package | |
| 0178-0485-08 | 0017804850800178048508 | 237 mL in 1 BOTTLE, PLASTIC (0178-0485-08)Marketed from Sep 15, 2011 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- OVACE Plus
- Generic name (nonproprietary)
- sulfacetamide sodium
- Active ingredients
- Sulfacetamide sodium — 100 mg/mL
- Dosage form
- Shampoo
- Route
- Topical
- Labeler
- Mission Pharmacal CompanyNDC labeler code 0178
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Sulfonamides (Chemical structure)
- Identifiers
- Product ID 0178-0485_45116f40-1802-b712-e063-6394a90a8712SPL ID 45116f40-1802-b712-e063-6394a90a8712SPL set ID 6a034465-e600-49cb-91bd-7b9ceee6ffc6RxCUI 832864, 901038UNII 4NRT660KJQ
- Pharmacologic class
- Sulfonamide Antibacterial
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
N400178048504followed by a unit qualifier and the quantityPackage 00178-0485-04. 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: This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff).
Excerpt only. Read the full label for complete information.
About NDC 0178-0485
- What is NDC 0178-0485?
- 0178-0485 is the product NDC for OVACE Plus (sulfacetamide sodium), Sulfacetamide sodium 100 mg/mL shampoo, listed with the FDA by Mission Pharmacal Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- OVACE Plus (Sulfacetamide sodium).
- What is the active ingredient?
- Sulfacetamide sodium.
- Who is the labeler?
- Mission Pharmacal Company, NDC labeler code 0178. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for OVACE Plus?
- 3 other product NDCs are listed under this name. See all OVACE Plus NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other OVACE Plus products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| OVACE Plussulfacetamide sodium | Sulfacetamide sodium 100 mg/mL | LiquidTopical | Mission Pharmacal Company | 0178-0490 | 00178-0490-0400178-0490-12 |
| Ovace Plussulfacetamide sodium | Sulfacetamide sodium 98 mg/g | LotionTopical | Mission Pharmacal Company | 0178-0620 | 00178-0620-04 |
| Ovace Plussodium sulfacetamide | Sulfacetamide sodium 100 mg/mL | LiquidTopical | Mission Pharmacal Company | 0178-0630 | 00178-0630-16 |