NDC codes

FDA NDC Directory
Product NDC (as listed)85401-020Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85401-0020Add 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
85401-020-23854010020232 BLISTER PACK in 1 BOX (85401-020-23) / 2 SUPPOSITORY in 1 BLISTER PACKMarketed from Aug 24, 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)
GYNTIMA Probiotica
Generic name (nonproprietary)
lactic acid, folic acid, sage
Active ingredients
Lactic acid, Dl- — 2 [hp_X]/1Sage — 3 [hp_X]/1Folic acid — 4 [hp_X]/1
Dosage form
Suppository
Route
Vaginal
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)Dietary Proteins (Chemical structure)Increased Histamine Release (Physiologic effect)Plant Proteins (Chemical structure)
Identifiers
Product ID 85401-020_31b83e91-bdd2-bdd1-e063-6394a90a16d7SPL ID 31b83e91-bdd2-bdd1-e063-6394a90a16d7SPL set ID 31b83e91-bdd1-bdd1-e063-6394a90a16d7UNII 3B8D35Y7S4, 065C5D077J, 935E97BOY8
Pharmacologic class
Non-Standardized Food Allergenic Extract; 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 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

N485401002023 followed by a unit qualifier and the quantity

Package 85401-0020-23. 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)

Women seeking preventive intimate care, particularly after: • Antibiotic or disinfectant use • Swimming, sexual activity, or other microbiome disturbances • Occasional mild discomfort or irritation not requiring pharmaceutical treatment

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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