Prescription drug · ANDA
Doxycycline Hyclate Delayed Release NDC 23155-141
doxycycline hyclate · Doxycycline hyclate 75 mg/1 · Tablet, Delayed release · Oral · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-141-01 | 23155014101 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-141-01)Marketed from Apr 30, 2013 | |
| 23155-141-05 | 23155014105 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-141-05)Marketed from Apr 30, 2013 | |
| 23155-141-06 | 23155014106 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-141-06)Marketed from Apr 30, 2013 |
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 Delayed ReleaseSuffix: DELAYED RELEASE
- Generic name (nonproprietary)
- doxycycline hyclate
- Active ingredients
- Doxycycline hyclate — 75 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200856
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 23155-141_74ed8d09-3486-4f4f-8df1-ea8f9f380741SPL ID 74ed8d09-3486-4f4f-8df1-ea8f9f380741SPL set ID f5ee43b2-d6ca-4819-a3d7-07f8421015d7RxCUI 406524, 434018, 799048, 1423080UNII 19XTS3T51UUPC 0323155611069, 0323155141016, 0323155142013
- 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
N423155014101followed by a unit qualifier and the quantityPackage 23155-0141-01. 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)
Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: • Rickettsial infections (1.1) • Sexually transmitted infections (1.2) • Respiratory tract infections (1.3) • Specific bacterial infections (1.4) • Ophthalmic infections (1.5) • Anthrax, including inhalational anthrax (post-exposure) (1.6) • Alternative treatment for selected infections when penicillin is contraindicated (1.7) • Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8) • Prophylaxis of malaria (1.9) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-releas…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200856
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 Delayed Releasedoxycycline hyclate | Doxycycline hyclate 150 mg/1 | Tablet, Delayed releaseOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-143 |
| Doxycycline Hyclate Delayed Releasedoxycycline hyclate | Doxycycline hyclate 200 mg/1 | Tablet, Delayed releaseOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-611 |
| Doxycycline Hyclate Delayed Releasedoxycycline hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Delayed releaseOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-142 |