Glutenstat NDC 44911-0670

NDC codes

FDA NDC Directory

Product NDC (as listed)44911-0670Labeler and product segments. Claims need a package NDC.

Product NDC at billing width44911-0670Add 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
44911-0670-1	44911067001	30 mL in 1 BOTTLE, DROPPER (44911-0670-1)Marketed from Apr 5, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): Glutenstat
Generic name (nonproprietary): alfalfa, zingiber officinale, cinchona officinalis, hydrastis canadensis, barley (grain), carbo vegetabilis, glyphosate, lycopodium clavatum, natrum muriaticum, nux vomica, oat (grain), pulsatilla (vulgaris), rye (grain), wheat (grain), gluten
Active ingredients: Medicago sativa whole — 4 [hp_X]/mLGinger — 4 [hp_X]/mLCinchona officinalis bark — 6 [hp_X]/mLGoldenseal — 6 [hp_X]/mLBarley — 12 [hp_X]/mLActivated charcoal — 12 [hp_X]/mLGlyphosate — 12 [hp_X]/mLLycopodium clavatum spore — 12 [hp_X]/mLSodium chloride — 12 [hp_X]/mLStrychnos nux-vomica seed — 12 [hp_X]/mLOat — 12 [hp_X]/mLPulsatilla vulgaris whole — 12 [hp_X]/mLRye — 12 [hp_X]/mLWheat — 12 [hp_X]/mLWheat gluten — 16 [hp_X]/mL
Dosage form: Liquid
Route: Oral
Labeler: Energique, Inc.
Product type: Over-the-counter drug
Marketing category: Unapproved homeopathic
Marketing start: Apr 5, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Allergens (Chemical structure)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Cell-mediated Immunity (Physiologic effect)Dietary Proteins (Chemical structure)Dietary Proteins (Chemical structure)Dietary Proteins (Chemical structure)Dietary Proteins (Chemical structure)Dietary Proteins (Chemical structure)Dietary Proteins (Chemical structure)Food Additives (Chemical structure)Grain Proteins (EXT)Grain Proteins (EXT)Grain Proteins (EXT)Grain Proteins (EXT)Grain Proteins (EXT)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased Histamine Release (Physiologic effect)Increased IgG Production (Physiologic effect)Plant Proteins (Chemical structure)Plant Proteins (Chemical structure)Seed Storage Proteins (Chemical structure)
Identifiers: Product ID 44911-0670_4884ad84-694d-41dc-9946-63e1cf2696b7SPL ID 4884ad84-694d-41dc-9946-63e1cf2696b7SPL set ID c6b867b6-74d9-4725-90d7-7d5d1fe61121UNII DJO934BRBD, C5529G5JPQ, S003A158SB, ZW3Z11D0JV, 5PWM7YLI7R, 2P3VWU3H10, 4632WW1X5A, C88X29Y479, 451W47IQ8X, 269XH13919, Z6J799EAJK, I76KB35JEV, 0R4AQI398X, 4J2I0SN84Y, 1534K8653JUPC 0363113701395
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 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

N444911067001 followed by a unit qualifier and the quantity

Package 44911-0670-01. 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 Apr 5, 2023.

Indications (excerpt from the label)

INDICATIONS: May temporarily relieve symptoms of bloating, abdominal pain, alternating constipation and diarrhea, poor digestion and brain fog.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)