NDC codes

FDA NDC Directory
Product NDC (as listed)61077-121Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61077-0121Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
61077-121-116107701211111 mL in 1 BOTTLE, DROPPER (61077-121-11)Marketed from Nov 6, 2013
61077-121-336107701213333 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

N461077012111 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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