Prescription drug · ANDA
Tetracycline Hydrochloride NDC 62135-225
Tetracycline hydrochloride 250 mg/1 · Capsule · Oral · Chartwell RX, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-225-01 | 62135022501 | 100 CAPSULE in 1 BOTTLE (62135-225-01)Marketed from Mar 1, 2020 | |
| 62135-225-05 | 62135022505 | 500 CAPSULE in 1 BOTTLE (62135-225-05)Marketed from Mar 1, 2020 | |
| 62135-225-20 | 62135022520 | 20 CAPSULE in 1 BOTTLE (62135-225-20)Marketed from Mar 1, 2020 | |
| 62135-225-60 | 62135022560 | 60 CAPSULE in 1 BOTTLE (62135-225-60)Marketed from Mar 1, 2021 |
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)
- Tetracycline Hydrochloride
- Generic name (nonproprietary)
- tetracycline hydrochloride
- Active ingredients
- Tetracycline hydrochloride — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Chartwell RX, LLC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 062752
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 62135-225_00d7f688-41b8-3498-e063-6394a90a8a3cSPL ID 00d7f688-41b8-3498-e063-6394a90a8a3cSPL set ID aa30113f-ab58-4f41-82c1-2fcb540d4a82RxCUI 198250, 198252UNII P6R62377KVUPC 0362135266608, 0362135225605, 0362135266011
- 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
N462135022501followed by a unit qualifier and the quantityPackage 62135-0225-01. 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 062752
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 250 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-766 |
| Tetracycline Hydrochloride | Tetracycline hydrochloride 500 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-767 |
| Tetracycline Hydrochloride | Tetracycline hydrochloride 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2427 |
| Tetracycline Hydrochloride | Tetracycline hydrochloride 250 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3170 |
| Tetracycline Hydrochloride | Tetracycline hydrochloride 500 mg/1 | CapsuleOral | Chartwell RX, LLC. | 62135-266 |
| Tetracycline Hydrochloride | Tetracycline hydrochloride 500 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. . | 68788-4134 |
| Tetracycline Hydrochloride | Tetracycline hydrochloride 500 mg/1 | CapsuleOral | Proficient Rx LP | 82804-292 |