Prescription drug · ANDA
Doxycycline Hyclate NDC 42806-362
Doxycycline hyclate 20 mg/1 · Tablet · Oral · EPIC PHARMA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-362-01 | 42806036201 | 100 TABLET in 1 BOTTLE (42806-362-01)Marketed from Aug 30, 2019 | |
| 42806-362-10 | 42806036210 | 1000 TABLET in 1 BOTTLE (42806-362-10)Marketed from Aug 30, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Doxycycline Hyclate
- Generic name (nonproprietary)
- doxycycline hyclate
- Active ingredients
- Doxycycline hyclate — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- EPIC PHARMA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065182
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 42806-362_00848e6e-f161-4fa1-887f-6e598fbf507cSPL ID 00848e6e-f161-4fa1-887f-6e598fbf507cSPL set ID b3cd7b44-db40-4ce5-895e-d4c85a0068aeRxCUI 283535UNII 19XTS3T51U
- Pharmacologic class
- Tetracycline-class Drug
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
N442806036201followed by a unit qualifier and the quantityPackage 42806-0362-01. 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 AND USAGE Doxycycline hyclate tablets, USP are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture susceptibility information is available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and s…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065182
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Doxycycline Hyclate | Doxycycline hyclate 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2256 |
| Doxycycline Hyclate | Doxycycline hyclate 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2526 |