Prescription drug · ANDA
Demeclocycline Hydrochloride NDC 42806-144
Demeclocycline hydrochloride 300 mg/1 · Tablet, Film coated · Oral · Epic Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-144-01 | 42806014401 | 100 TABLET, FILM COATED in 1 BOTTLE (42806-144-01)Marketed from Feb 2, 2015 | |
| 42806-144-30 | 42806014430 | 30 TABLET, FILM COATED in 1 BOTTLE (42806-144-30)Marketed from Feb 2, 2015 | |
| 42806-144-48 | 42806014448 | 48 TABLET, FILM COATED in 1 BOTTLE (42806-144-48)Marketed from Feb 2, 2015 |
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 hydrochloride
- Active ingredients
- Demeclocycline hydrochloride — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Epic Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065447
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 42806-144_b84008e7-52db-4b3e-a12e-cb939852ff0fSPL ID b84008e7-52db-4b3e-a12e-cb939852ff0fSPL set ID 645af8f4-0843-4afb-9ddc-f587f38adb68RxCUI 905341, 905347UNII 29O079NTYTUPC 0342806144480, 0342806143018
- 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
N442806014401followed by a unit qualifier and the quantityPackage 42806-0144-01. 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 Demeclocycline hydrochloride tablets USP is 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 ur…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065447
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 Hydrochloride | Demeclocycline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-143 |
| Demeclocycline Hydrochloride | Demeclocycline hydrochloride 150 mg/1 | Tablet, Film coatedOral | PuraCap Laboratories LLC | 24658-710 |
| Demeclocycline Hydrochloride | Demeclocycline hydrochloride 300 mg/1 | Tablet, Film coatedOral | PuraCap Laboratories LLC | 24658-711 |