Prescription drug · ANDA
Demeclocycline Hydrochloride NDC 24658-711
Demeclocycline hydrochloride 300 mg/1 · Tablet, Film coated · Oral · PuraCap Laboratories LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24658-711-48 | 24658071148 | 48 TABLET, FILM COATED in 1 BOTTLE (24658-711-48)Marketed from Oct 7, 2017 |
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
- PuraCap Laboratories LLCNDC labeler code 24658
- 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 24658-711_aa40e353-18db-4553-8f8d-a434eac8ed1fSPL ID aa40e353-18db-4553-8f8d-a434eac8ed1fSPL set ID 88e03cb0-25f5-41a5-b77f-58ab8f3be181RxCUI 905341, 905347UNII 29O079NTYTUPC 0324658711485, 0324658710013
- 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
N424658071148followed by a unit qualifier and the quantityPackage 24658-0711-48. 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.
About NDC 24658-711
- What is NDC 24658-711?
- 24658-711 is the product NDC for Demeclocycline Hydrochloride, Demeclocycline hydrochloride 300 mg/1 tablet, film coated, listed with the FDA by PuraCap Laboratories LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Demeclocycline Hydrochloride.
- What is the active ingredient?
- Demeclocycline hydrochloride.
- Who is the labeler?
- PuraCap Laboratories LLC, NDC labeler code 24658. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Demeclocycline Hydrochloride?
- 9 other product NDCs are listed under this name. See all Demeclocycline Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Demeclocycline Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Demeclocycline Hydrochloridedemeclocycline | Demeclocycline hydrochloride 300 mg/1 | TabletOral | American Health Packaging | 60687-705 | 60687-0705-65 |
| Demeclocycline Hydrochloridedemeclocycline | Demeclocycline hydrochloride 150 mg/1 | TabletOral | American Health Packaging | 60687-691 | 60687-0691-01 |
| Demeclocycline Hydrochloridedemeclocycline | Demeclocycline hydrochloride 150 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-554 | 53746-0554-01 |
| Demeclocycline Hydrochloridedemeclocycline | Demeclocycline hydrochloride 300 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-555 | 53746-0555-48 |
| Demeclocycline Hydrochloride | Demeclocycline hydrochloride 150 mg/1 | Tablet, Film coatedOral | PuraCap Laboratories LLC | 24658-710 | 24658-0710-01 |
| Demeclocycline Hydrochloride | Demeclocycline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-143 | 42806-0143-0142806-0143-0542806-0143-30 |
| Demeclocycline Hydrochloride | Demeclocycline hydrochloride 300 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-144 | 42806-0144-0142806-0144-3042806-0144-48 |
| Demeclocycline Hydrochloridedemeclocycline | Demeclocycline hydrochloride 150 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-554 | 65162-0554-10 |
| Demeclocycline Hydrochloridedemeclocycline | Demeclocycline hydrochloride 300 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-555 | 65162-0555-48 |
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 | PuraCap Laboratories LLC | 24658-710 |
| Demeclocycline Hydrochloride | Demeclocycline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-143 |
| Demeclocycline Hydrochloride | Demeclocycline hydrochloride 300 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-144 |