Prescription drug · ANDA
Tetracycline Hydrochloride NDC 69238-1522
Tetracycline hydrochloride 250 mg/1 · Capsule · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1522-1 | 69238152201 | 100 CAPSULE in 1 BOTTLE (69238-1522-1)Marketed from Sep 21, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Tetracycline Hydrochloride
- Generic name (nonproprietary)
- tetracycline hydrochloride
- Active ingredients
- Tetracycline hydrochloride — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210674
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 69238-1522_15697aca-7bc8-4a3a-a935-1b79790a919eSPL ID 15697aca-7bc8-4a3a-a935-1b79790a919eSPL set ID ae29aa18-6efb-47c9-bbd7-cbe8af1b7f38RxCUI 198250, 198252UNII P6R62377KVUPC 0369238152319, 0369238152210
- 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
N469238152201followed by a unit qualifier and the quantityPackage 69238-1522-01. 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 To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the condit…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210674
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 |
|---|---|---|---|---|
| Tetracycline Hydrochloride | Tetracycline hydrochloride 500 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1523 |
| Tetracycline Hydrochloride | Tetracycline hydrochloride 250 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1522 |
| Tetracycline Hydrochloride | Tetracycline hydrochloride 500 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1523 |