Over-the-counter drug · ANDA
Lagicam antifungal (Miconazole nitrate) NDC 50066-070
Miconazole nitrate 40 mg/g · Cream · Vaginal · Genomma Lab USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50066-070-01 | 5006600700150066007001 | 1 TUBE, WITH APPLICATOR in 1 CARTON (50066-070-01) / 25 g in 1 TUBE, WITH APPLICATORMarketed from Sep 11, 2023 | |
| 50066-070-03 | 5006600700350066007003 | 1 TUBE, WITH APPLICATOR in 1 CARTON (50066-070-03) / 25 g in 1 TUBE, WITH APPLICATORMarketed from Oct 18, 2013 |
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)
- Lagicam antifungalSuffix: antifungal
- Generic name (nonproprietary)
- miconazole nitrate
- Active ingredients
- Miconazole nitrate — 40 mg/g
- Dosage form
- Cream
- Route
- Vaginal
- Labeler
- Genomma Lab USA, Inc.NDC labeler code 50066
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076773
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)
- Identifiers
- Product ID 50066-070_38f5f7e1-41c1-166e-e063-6394a90a7f56SPL ID 38f5f7e1-41c1-166e-e063-6394a90a7f56SPL set ID 85043273-7411-48f5-8ad4-3f00e03cafa3RxCUI 998544, 1440002UNII VW4H1CYW1K
- Pharmacologic class
- Azole Antifungal
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
N450066007001followed by a unit qualifier and the quantityPackage 50066-0070-01. 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)
Use treats vaginal yeast infections
Excerpt only. Read the full label for complete information.
About NDC 50066-070
- What is NDC 50066-070?
- 50066-070 is the product NDC for Lagicam antifungal (miconazole nitrate), Miconazole nitrate 40 mg/g cream, listed with the FDA by Genomma Lab USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lagicam antifungal (Miconazole Nitrate).
- What is the active ingredient?
- Miconazole nitrate.
- Who is the labeler?
- Genomma Lab USA, Inc., NDC labeler code 50066. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lagicam antifungal?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 076773
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 3miconazole nitrate | Miconazole nitrate 40 mg/g | CreamVaginal | TARGET Corporation | 11673-391 |
| Miconazole Nitrate | Miconazole nitrate 40 mg/g | CreamVaginal | Sun Pharmaceutical Industries, Inc. | 51672-2070 |