Prescription drug · ANDA
doxycycline hyclate NDC 70436-201
Doxycycline anhydrous 200 mg/20mL · Powder, For solution · Intravenous · Slate Run Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70436-201-82 | 70436020182 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-201-82) / 20 mL in 1 VIAL, SINGLE-DOSE (70436-201-36)Marketed from Jul 22, 2024 |
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 anhydrous — 200 mg/20mL
- Dosage form
- Powder, For solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217685
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 70436-201_54e53c00-7eb1-3535-e063-6294a90abdfeSPL ID 54e53c00-7eb1-3535-e063-6294a90abdfeSPL set ID f31e69fc-e513-40e4-91b5-22ccf1ed9437UNII 334895S862
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N470436020182followed by a unit qualifier and the quantityPackage 70436-0201-82. 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 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline for Injection, USP and other antibacterial drugs, Doxycycline for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline for Injection, USP is indicated in infections caused by the following microorganisms: Rickettsiae…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217685
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 anhydrous 100 mg/10mL | Powder, For solutionIntravenous | Slate Run Pharmaceuticals, LLC | 70436-032 |