NDC codes

FDA NDC Directory
Product NDC (as listed)43857-0198Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43857-0198Add 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
43857-0198-1438570198014385701980160 mL in 1 BOTTLE, DROPPER (43857-0198-1)Marketed from Nov 8, 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)
Hydrate ISuffix: I
Generic name (nonproprietary)
coffea tosta, ginkgo biloba, germanium sesquioxide, silicea
Active ingredients
Coffea arabica seed, Roasted — 1 [hp_X]/mLGinkgo — 6 [hp_X]/mLGermanium sesquioxide — 8 [hp_X]/mLSilicon dioxide — 8 [hp_X]/mL
Dosage form
Liquid
Route
Oral
Labeler
BioActive Nutritional, Inc.NDC labeler code 43857
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Identifiers
Product ID 43857-0198_f75a0424-48db-41e5-aa5d-10cfa74269a7SPL ID f75a0424-48db-41e5-aa5d-10cfa74269a7SPL set ID c0c8d350-0257-4484-acd8-f852350173dbUNII 9H58JRT35E, 19FUJ2C58T, 96WE91N25T, ETJ7Z6XBU4UPC 0210184341640

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

N443857019801 followed by a unit qualifier and the quantity

Package 43857-0198-01. 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: For temporary relief of dry mouth, dyspepsia, infrequent urination, constipation alternated with diarrhea, chronic myalgia, headache, and low back pain.** **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)

About NDC 43857-0198

What is NDC 43857-0198?
43857-0198 is the product NDC for Hydrate I, Coffea arabica seed, Roasted 1 [hp_X]/mL + 3 more ingredients liquid, listed with the FDA by BioActive Nutritional, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Hydrate I (Coffea Tosta, Ginkgo Biloba, Germanium Sesquioxide, Silicea).
What is the active ingredient?
Coffea arabica seed, Roasted, Ginkgo, Germanium sesquioxide, Silicon dioxide.
Who is the labeler?
BioActive Nutritional, Inc., NDC labeler code 43857. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hydrate I?
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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