NDC codes

FDA NDC Directory
Product NDC (as listed)61077-005Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61077-0005Add 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
61077-005-116107700051111 mL in 1 BOTTLE, DROPPER (61077-005-11)Marketed from Nov 6, 2013
61077-005-336107700053333 mL in 1 BOTTLE, DROPPER (61077-005-33)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-BI Hemorrhoids Formula
Generic name (nonproprietary)
calendula officinallis, hamamelis virginiana
Active ingredients
Calendula officinalis flowering top — 12 [hp_C]/11mLHamamelis virginiana root bark/stem bark — 6 [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
Identifiers
Product ID 61077-005_b6a0fff6-0ded-49d8-be48-a2a2d17bcd53SPL ID b6a0fff6-0ded-49d8-be48-a2a2d17bcd53SPL set ID a6f59c34-e252-4458-8ce4-01e2d3028aa8UNII 18E7415PXQ, T7S323PKJS

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

N461077000511 followed by a unit qualifier and the quantity

Package 61077-0005-11. 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 hemorrhoid symptoms such as burning, soreness and minor bleeding

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61077-005

What is NDC 61077-005?
61077-005 is the product NDC for H-BI Hemorrhoids Formula, Calendula officinalis flowering top 12 [hp_C]/11mL; Hamamelis virginiana root bark/stem bark 6 [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-BI Hemorrhoids Formula (Calendula officinallis, hamamelis virginiana).
What is the active ingredient?
Calendula officinalis flowering top, Hamamelis virginiana root bark/stem bark.
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-BI Hemorrhoids 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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