Over-the-counter drug · ANDA
Miconazole 3 Combination Pack (Miconazole nitrate) NDC 49035-345
Kit · EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49035-345-03 | 4903503450349035034503 | 1 KIT in 1 PACKAGE, COMBINATION (49035-345-03) * 3 SUPPOSITORY in 1 BLISTER PACK * 9 g in 1 TUBEMarketed from May 1, 2020 |
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)
- Miconazole 3 Combination Pack
- Generic name (nonproprietary)
- miconazole nitrate
- Dosage form
- Kit
- Labeler
- EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)NDC labeler code 49035
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074926
- Marketing start
- Marketing end
- Identifiers
- Product ID 49035-345_c488ea40-99f6-433e-8b73-13f723cb1decSPL ID c488ea40-99f6-433e-8b73-13f723cb1decSPL set ID 50f2a26c-8203-4a10-8d0d-ad0f9fadb6bcRxCUI 992765, 992766, 998540UPC 0681131353298
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N449035034503followed by a unit qualifier and the quantityPackage 49035-0345-03. 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)
Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
Excerpt only. Read the full label for complete information.
About NDC 49035-345
- What is NDC 49035-345?
- 49035-345 is the product NDC for Miconazole 3 Combination Pack (miconazole nitrate) kit, listed with the FDA by EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC). It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Miconazole 3 Combination Pack (Miconazole Nitrate).
- Who is the labeler?
- EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC), NDC labeler code 49035. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Miconazole 3 Combination Pack?
- 2 other product NDCs are listed under this name. See all Miconazole 3 Combination Pack NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Miconazole 3 Combination Pack products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Miconazole 3 Combination Packmiconazole nitrate | — | Kit | Chain Drug Consortium, LLC | 68016-731 | 68016-0731-04 |
| Miconazole 3 Combination Packmiconazole nitrate | — | Kit | CVS Pharmacy | 59779-773 | 59779-0773-43 |
Other NDCs under ANDA 074926
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 |
|---|---|---|---|---|
| Miconazole 3 Combination Packmiconazole nitrate | — | Kit | CVS Pharmacy | 59779-773 |
| Miconazole 3 Combination Packmiconazole nitrate | — | Kit | Chain Drug Consortium, LLC | 68016-731 |
| MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kitmiconazole nitrate | — | Kit | Cosette Pharmaceuticals, Inc. | 0713-0593 |