Over-the-counter drug · UNAPPROVED HOMEOPATHIC
Hydrate II NDC 43857-0080
Coffea arabica seed, Roasted 1 [hp_X]/mL + 6 more ingredients · Liquid · Oral · BioActive Nutritional, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43857-0080-1 | 43857008001 | 60 mL in 1 BOTTLE, DROPPER (43857-0080-1)Marketed from Aug 16, 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 IISuffix: II
- Generic name (nonproprietary)
- coffea tosta, avena sativa, equisetum hyemale, hypericum performatum, ginkgo biloba, germanium sesquioxide, silicea
- Active ingredients
- Coffea arabica seed, Roasted — 1 [hp_X]/mLAvena sativa flowering top — 3 [hp_X]/mLEquisetum hyemale whole — 3 [hp_X]/mLHypericum perforatum whole — 3 [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 43857-0080_7bf668c6-531a-4c35-adfd-89295fe1e85cSPL ID 7bf668c6-531a-4c35-adfd-89295fe1e85cSPL set ID 2d3657d9-d4f4-426c-b381-dbfde9b8e2cdUNII 9H58JRT35E, MA9CQJ3F7F, 59677RXH25, XK4IUX8MNB, 19FUJ2C58T, 96WE91N25T, ETJ7Z6XBU4
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
N443857008001followed by a unit qualifier and the quantityPackage 43857-0080-01. 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)
INDICATIONS: For temporary relief of dry mouth, dyspepsia, infrequent urination, constipation alternated with diarrhea, chronic myalgia, headaches and low back pain.
Excerpt only. Read the full label for complete information.
About NDC 43857-0080
- What is NDC 43857-0080?
- 43857-0080 is the product NDC for Hydrate II, Coffea arabica seed, Roasted 1 [hp_X]/mL + 6 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 II (Coffea Tosta, Avena Sativa, Equisetum Hyemale, Hypericum Performatum, Ginkgo Biloba, Germanium Sesquioxide, Silicea).
- What is the active ingredient?
- Coffea arabica seed, Roasted, Avena sativa flowering top, Equisetum hyemale whole, Hypericum perforatum whole, 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 II?
- 1 other product NDC are listed under this name. See all Hydrate II NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydrate II products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydrate IIberber aqui, beta vulg, boldo, carduus mar, chelidonium maj, hordeum vulgare, iris vers, rosmarinus, taraxacum, avena, eleutherococcus senticosus, xanthoxylum, equisetum hyem, hypericum, ulmus fulv, gettysburg aqua, glycyrrhiza, wildbad aqua, carlsbad aqua, atp, hydrogen, nat mur, oxygen, silicea, wiesbaden aqua | Berberis aquifolium root bark 8 [hp_X]/mL + 20 more ingredients | LiquidOral | Zorex International | 81825-0001 | 81825-0001-02 |