Prescription drug · ANDA
Demeclocycline Hydrochloride (demeclocycline) NDC 65162-554
Demeclocycline hydrochloride 150 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-554-10 | 65162055410 | 100 TABLET in 1 BOTTLE (65162-554-10)Marketed from Feb 27, 2008 |
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)
- Demeclocycline Hydrochloride
- Generic name (nonproprietary)
- demeclocycline
- Active ingredients
- Demeclocycline hydrochloride — 150 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065425
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 65162-554_4cd13048-b500-48bc-b998-e47aafff605eSPL ID 4cd13048-b500-48bc-b998-e47aafff605eSPL set ID 4ff23e3b-e111-47fd-9776-1d89d6da049bRxCUI 905341, 905347UNII 29O079NTYTUPC 0365162554106, 0365162555486
- Pharmacologic class
- Tetracycline-class Antimicrobial
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
N465162055410followed by a unit qualifier and the quantityPackage 65162-0554-10. 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 Demeclocycline HCl tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae; Respiratory tract infections caused by Mycoplasma pneumoniae Lymphogranuloma venereum due to Chlamydia trachomatis Psittacosis (Ornithosis) due to Chlamydia psittaci Trachoma due to Chlamydia trachomatis , although the infectious agent is not always eliminated as judged by immunofluorescence Inclusion conjunctivitis caused by Chlamydia trachomatis Nongonococcal urethritis in adults cause…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065425
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 |
|---|---|---|---|---|
| Demeclocycline Hydrochloridedemeclocycline | Demeclocycline hydrochloride 300 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-555 |
| Demeclocycline Hydrochloridedemeclocycline | Demeclocycline hydrochloride 150 mg/1 | TabletOral | American Health Packaging | 60687-691 |
| Demeclocycline Hydrochloridedemeclocycline | Demeclocycline hydrochloride 300 mg/1 | TabletOral | American Health Packaging | 60687-705 |
| Demeclocycline Hydrochloridedemeclocycline | Demeclocycline hydrochloride 150 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-554 |
| Demeclocycline Hydrochloridedemeclocycline | Demeclocycline hydrochloride 300 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-555 |