Prescription drug · ANDA
Doxycycline Hyclate NDC 72789-309
Doxycycline hyclate 20 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-309-01 | 72789030901 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-309-01)Marketed from Mar 15, 2023 | |
| 72789-309-60 | 72789030960 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-309-60)Marketed from Mar 27, 2023 | |
| 72789-309-93 | 72789030993 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-309-93)Marketed from Mar 27, 2023 |
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, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065134
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 72789-309_38052f8d-1d68-b250-e063-6394a90a8b48SPL ID 38052f8d-1d68-b250-e063-6394a90a8b48SPL set ID 294c6fc3-e7ca-46ea-b062-a27dd7b0bc97RxCUI 283535UNII 19XTS3T51UUPC 0372789309934
- 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
N472789030901followed by a unit qualifier and the quantityPackage 72789-0309-01. 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 is 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.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065134
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 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 53489-647 |