Over-the-counter drug · UNAPPROVED HOMEOPATHIC
Hydrate I NDC 43857-0198
coffea tosta, ginkgo biloba, germanium sesquioxide, silicea · Coffea arabica seed, Roasted 1 [hp_X]/mL + 3 more ingredients · Liquid · Oral · BioActive Nutritional, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43857-0198-1 | 4385701980143857019801 | 60 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
N443857019801followed by a unit qualifier and the quantityPackage 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.
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.