Prescription drug · ANDA
Demeclocycline Hydrochloride (Demeclocycline) NDC 60687-691
Demeclocycline hydrochloride 150 mg/1 · Tablet · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-691-01 | 60687069101 | 100 BLISTER PACK in 1 CARTON (60687-691-01) / 1 TABLET in 1 BLISTER PACK (60687-691-11)Marketed from Sep 6, 2022 |
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
- American Health PackagingNDC labeler code 60687
- 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 60687-691_230a18ee-ef80-61c6-e063-6394a90acb5dSPL ID 230a18ee-ef80-61c6-e063-6394a90acb5dSPL set ID e6adaf70-5ff9-4395-bff1-0f332090cb80RxCUI 905341, 905347UNII 29O079NTYT
- 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
N460687069101followed by a unit qualifier and the quantityPackage 60687-0691-01. 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 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 ad…
Excerpt only. Read the full label for complete information.
About NDC 60687-691
- What is NDC 60687-691?
- 60687-691 is the product NDC for Demeclocycline Hydrochloride (demeclocycline), Demeclocycline hydrochloride 150 mg/1 tablet, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Demeclocycline Hydrochloride (Demeclocycline).
- What is the active ingredient?
- Demeclocycline hydrochloride.
- Who is the labeler?
- American Health Packaging, NDC labeler code 60687. 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 300 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-555 | 53746-0555-48 |
| Demeclocycline Hydrochloridedemeclocycline | Demeclocycline hydrochloride 150 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-554 | 53746-0554-01 |
| Demeclocycline Hydrochloride | Demeclocycline hydrochloride 300 mg/1 | Tablet, Film coatedOral | PuraCap Laboratories LLC | 24658-711 | 24658-0711-48 |
| 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 300 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-555 | 65162-0555-48 |
| Demeclocycline Hydrochloridedemeclocycline | Demeclocycline hydrochloride 150 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-554 | 65162-0554-10 |
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 of New York LLC | 53746-555 |
| Demeclocycline Hydrochloridedemeclocycline | Demeclocycline hydrochloride 300 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-555 |
| Demeclocycline Hydrochloridedemeclocycline | Demeclocycline hydrochloride 150 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-554 |
| 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 |