NDC codes

FDA NDC Directory
Product NDC (as listed)64578-0130Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64578-0130Add 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
64578-0130-1645780130016457801300130 mL in 1 BOTTLE, DROPPER (64578-0130-1)Marketed from Jul 14, 2016

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)
GB-Tone
Generic name (nonproprietary)
ammi visnaga, atropinum sulphuricum, boldo, carduus marianus, chelidonium majus, echinacea, fel tauri, hepar suis, hydrastis canadensis, leptandra virginica, magnesia phosphorica, natrum phosphoricum, podophyllum peltatum, taraxacum officinale
Active ingredients
Ammi visnaga fruit — 12 [hp_X]/mLAtropine sulfate — 12 [hp_X]/mLPeumus boldus leaf — 4 [hp_X]/mLMilk thistle — 4 [hp_X]/mLChelidonium majus — 12 [hp_X]/mLEchinacea angustifolia — 4 [hp_X]/mLBos taurus bile — 8 [hp_X]/mLPork liver — 9 [hp_X]/mLGoldenseal — 5 [hp_X]/mLVeronicastrum virginicum root — 12 [hp_X]/mLMagnesium phosphate, Dibasic trihydrate — 12 [hp_X]/mLSodium phosphate, Dibasic, Heptahydrate — 6 [hp_X]/mLPodophyllum — 12 [hp_X]/mLTaraxacum officinale — 4 [hp_X]/mL
Dosage form
Liquid
Route
Oral
Labeler
Energetix CorpNDC labeler code 64578
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
Identifiers
Product ID 64578-0130_69332262-99a6-400f-9c7d-12cc674df851SPL ID 69332262-99a6-400f-9c7d-12cc674df851SPL set ID 5620a1dc-b59c-4489-a548-20f3e488287fUNII 3UN285QN0C, 03J5ZE7KA5, Q4EWM09M3O, U946SH95EE, 7E889U5RNN, VB06AV5US8, ET3651ZLOU, 6EC706HI7F, ZW3Z11D0JV, M2O62YTN42, HF539G9L3Q, 70WT22SF4B, 2S713A4VP3, 39981FM375UPC 0364578030310
Pharmacologic class
Anticholinergic; Calculi Dissolution Agent; Cholinergic Muscarinic Antagonist; Osmotic Laxative

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

N464578013001 followed by a unit qualifier and the quantity

Package 64578-0130-01. 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 .

Indications (excerpt from the label)

USES: Temporary relief of abdominal discomfort, indigestion, headaches.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64578-0130

What is NDC 64578-0130?
64578-0130 is the product NDC for GB-Tone, Ammi visnaga fruit 12 [hp_X]/mL + 13 more ingredients liquid, listed with the FDA by Energetix Corp. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
GB-Tone (Ammi Visnaga, Atropinum Sulphuricum, Boldo, Carduus Marianus, Chelidonium Majus, Echinacea, Fel Tauri, Hepar Suis, Hydrastis Canadensis, Leptandra Virginica, Magnesia Phosphorica, Natrum Phosphoricum, Podophyllum Peltatum, Taraxacum Officinale).
What is the active ingredient?
Ammi visnaga fruit, Atropine sulfate, Peumus boldus leaf, Milk thistle, Chelidonium majus, Echinacea angustifolia, Bos taurus bile, Pork liver, Goldenseal, Veronicastrum virginicum root, Magnesium phosphate, Dibasic trihydrate, Sodium phosphate, Dibasic, Heptahydrate, Podophyllum, Taraxacum officinale.
Who is the labeler?
Energetix Corp, NDC labeler code 64578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for GB-Tone?
1 other product NDC are listed under this name. See all GB-Tone NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other GB-Tone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
GB-Toneammi vis, atropinum sulphuricum, boldo, carduus mar, chelidonium maj, echinacea, fel tauri, hepar suis, hydrastis, leptandra, mag phos, nat phos, podoph pelt, taraxacumVisnaga daucoides fruit 12 [hp_X]/59.1mL + 13 more ingredientsLiquidOralEnergetix Corporation64578-015964578-0159-01

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