Prescription drug · ANDA
Doxycycline Hyclate NDC 69668-515
Doxycycline hyclate 150 mg/1 · Tablet, Delayed release · Oral · Sonoma Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69668-515-30 | 69668051530 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (69668-515-30)Marketed from May 10, 2018 |
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 — 150 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Sonoma Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207494
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 69668-515_6ce404bd-62b7-4aeb-e053-2a91aa0ade68SPL ID 6ce404bd-62b7-4aeb-e053-2a91aa0ade68SPL set ID 4fa26176-a730-48ed-9659-e2f64212f418RxCUI 799048UNII 19XTS3T51UUPC 0369668515302
- 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
N469668051530followed by a unit qualifier and the quantityPackage 69668-0515-30. 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)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, doxycycline hyclate delayed-release tablets 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 is a tetracycline-class antibacterial indicated in the following conditions or diseases: Doxy…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207494
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 50 mg/1 | Tablet, Delayed releaseOral | Solco Healthcare US LLC | 43547-462 |
| Doxycycline Hyclate | Doxycycline hyclate 150 mg/1 | Tablet, Delayed releaseOral | Solco Healthcare US LLC | 43547-324 |
| Doxycycline Hyclate | Doxycycline hyclate 200 mg/1 | Tablet, Delayed releaseOral | Solco Healthcare US LLC | 43547-325 |