Prescription drug · ANDA
Tetracycline Hydrochloride NDC 82644-870
Tetracycline hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Pharmaka Generics Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82644-870-60 | 8264408706082644087060 | 60 TABLET, FILM COATED in 1 BOTTLE (82644-870-60)Marketed from Jan 19, 2024 |
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 — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Pharmaka Generics Inc.NDC labeler code 82644
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 061147
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 82644-870_3d44a562-4fde-4867-90e6-433ea752bb3cSPL ID 3d44a562-4fde-4867-90e6-433ea752bb3cSPL set ID c522c860-84ce-4c61-ab72-077de73195dfRxCUI 313252, 313254UNII P6R62377KV
- 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
N482644087060followed by a unit qualifier and the quantityPackage 82644-0870-60. 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 hydrochloride tablets are indicated in the treatment of infections caused by susceptible strains of the designated …
Excerpt only. Read the full label for complete information.
About NDC 82644-870
- What is NDC 82644-870?
- 82644-870 is the product NDC for Tetracycline Hydrochloride, Tetracycline hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Pharmaka Generics Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tetracycline Hydrochloride.
- What is the active ingredient?
- Tetracycline hydrochloride.
- Who is the labeler?
- Pharmaka Generics Inc., NDC labeler code 82644. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tetracycline Hydrochloride?
- 21 other product NDCs are listed under this name. See all Tetracycline Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tetracycline 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) |
|---|---|---|---|---|---|
| Tetracycline Hydrochloride | Tetracycline hydrochloride 500 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. . | 68788-4134 | 68788-4134-03 |
| Tetracycline Hydrochloride | Tetracycline hydrochloride 500 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8853 | 68788-8853-03 |
| tetracycline hydrochloride | Tetracycline hydrochloride 250 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-017 | 23155-0017-01 |
| tetracycline hydrochloride | Tetracycline hydrochloride 500 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-018 | 23155-0018-01 |
| Tetracycline Hydrochloride | Tetracycline hydrochloride 250 mg/1 | Tablet, Film coatedOral | Pharmaka Generics Inc. | 82644-087 | 82644-0087-60 |
| Tetracycline Hydrochloride | Tetracycline hydrochloride 250 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1522 | 60219-1522-01 |
| Tetracycline Hydrochloride | Tetracycline hydrochloride 500 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1523 | 60219-1523-01 |
| Tetracycline Hydrochloride | Tetracycline hydrochloride 250 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-766 | 23155-0766-01 |
| Tetracycline Hydrochloride | Tetracycline hydrochloride 500 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-767 | 23155-0767-01 |
| Tetracycline Hydrochloride | Tetracycline hydrochloride 500 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2427 | 71335-2427-0171335-2427-0271335-2427-03+5 more |
Other NDCs under ANDA 061147
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 | Tablet, Film coatedOral | Pharmaka Generics Inc. | 82644-087 |