What is NDC 85631-010?

85631-010 is the product NDC for Breast Nodule, Citrus medica var. Sarcodactylis whole 30 mg/g + 8 more ingredients capsule, listed with the FDA by Bispit Canada Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Citrus medica var. Sarcodactylis whole, Black pepper, Rosa rugosa flower, Prunus persica seed, Tangerine peel, Crataegus rivularis whole, Taraxacum officinale, Curcuma aromatica root, Angelica sinensis root.

Bispit Canada Ltd., NDC labeler code 85631. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Breast Nodule?

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.

Breast Nodule NDC 85631-010 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)85631-010Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85631-0010Add 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 NDC	11-digit (billing)	Package	Copy
85631-010-01	85631001001	60 CAPSULE in 1 BOTTLE (85631-010-01) / 1 g in 1 CAPSULEMarketed from Nov 3, 2025

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): Breast Nodule
Generic name (nonproprietary): breast nodule
Active ingredients: Citrus medica var. Sarcodactylis whole — 30 mg/gBlack pepper — 2 mg/gRosa rugosa flower — 70 mg/gPrunus persica seed — 30 mg/gTangerine peel — 30 mg/gCrataegus rivularis whole — 30 mg/gTaraxacum officinale — 90 mg/gCurcuma aromatica root — 510 mg/gAngelica sinensis root — 30 mg/g
Dosage form: Capsule
Route: Oral
Labeler: Bispit Canada Ltd.NDC labeler code 85631
Product type: Over-the-counter drug
Marketing category: Unapproved homeopathic
Marketing start: Nov 3, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Dietary Proteins (Chemical structure)Increased Histamine Release (Physiologic effect)Vegetable Proteins (Chemical structure)
Identifiers: Product ID 85631-010_42ad5c57-9493-7742-e063-6394a90a6010SPL ID 42ad5c57-9493-7742-e063-6394a90a6010SPL set ID 42ad5c57-9492-7742-e063-6394a90a6010UNII W34IF71M2W, KM66971LVF, 969IQC5YJU, V9C81470RR, JU3D414057, WLL8F7NDKG, 39981FM375, C7X957O5YS, B66F4574UGUPC 0850066597286
Pharmacologic class: Non-Standardized Food 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N485631001001 followed by a unit qualifier and the quantity

Package 85631-0010-01. 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 Nov 3, 2025.

Indications (excerpt from the label)

Dosage:For prevention: once per day,2 tablets per dosing.Patient with nodule: twice per day.2 tablets per dosing (doubled forsevere patient).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85631-010

What is NDC 85631-010?: 85631-010 is the product NDC for Breast Nodule, Citrus medica var. Sarcodactylis whole 30 mg/g + 8 more ingredients capsule, listed with the FDA by Bispit Canada Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Breast Nodule.
What is the active ingredient?: Citrus medica var. Sarcodactylis whole, Black pepper, Rosa rugosa flower, Prunus persica seed, Tangerine peel, Crataegus rivularis whole, Taraxacum officinale, Curcuma aromatica root, Angelica sinensis root.
Who is the labeler?: Bispit Canada Ltd., NDC labeler code 85631. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Breast Nodule?: 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.