Over-the-counter drug · UNAPPROVED HOMEOPATHIC
H-Rosacea Formula (Belladonna, nux vomica) NDC 61077-121
Atropa belladonna 6 [hp_C]/11mL; Strychnos nux-vomica seed 12 [hp_C]/11mL · Oil · Topical · Healing Natural Oils LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61077-121-11 | 61077012111 | 11 mL in 1 BOTTLE, DROPPER (61077-121-11)Marketed from Nov 6, 2013 | |
| 61077-121-33 | 61077012133 | 33 mL in 1 BOTTLE, DROPPER (61077-121-33)Marketed from Nov 6, 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)
- H-Rosacea Formula
- Generic name (nonproprietary)
- belladonna, nux vomica
- Active ingredients
- Atropa belladonna — 6 [hp_C]/11mLStrychnos nux-vomica seed — 12 [hp_C]/11mL
- Dosage form
- Oil
- Route
- Topical
- Labeler
- Healing Natural Oils LLCNDC labeler code 61077
- Product type
- Over-the-counter drug
- Marketing category
- Unapproved homeopathic
- Marketing start
- Listing expires
- Other FDA classes
- Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)Plant Proteins (Chemical structure)Seed Storage Proteins (Chemical structure)
- Identifiers
- Product ID 61077-121_34491b5f-1c37-4c7d-9093-0ee74062fbc2SPL ID 34491b5f-1c37-4c7d-9093-0ee74062fbc2SPL set ID f00b0028-4340-4219-8890-f66590a2a04dUNII WQZ3G9PF0H, 269XH13919
- Pharmacologic class
- Non-Standardized Plant Allergenic Extract
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
N461077012111followed by a unit qualifier and the quantityPackage 61077-0121-11. 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: For the temporary relief of rosacea symptoms such as redness and irritation
Excerpt only. Read the full label for complete information.
About NDC 61077-121
- What is NDC 61077-121?
- 61077-121 is the product NDC for H-Rosacea Formula, Atropa belladonna 6 [hp_C]/11mL; Strychnos nux-vomica seed 12 [hp_C]/11mL oil, listed with the FDA by Healing Natural Oils LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- H-Rosacea Formula (Belladonna, nux vomica).
- What is the active ingredient?
- Atropa belladonna, Strychnos nux-vomica seed.
- Who is the labeler?
- Healing Natural Oils LLC, NDC labeler code 61077. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for H-Rosacea Formula?
- 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.