Prescription drug · ANDA
Tetracycline Hydrochloride NDC 68788-8853
Tetracycline hydrochloride 500 mg/1 · Capsule · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8853-3 | 6878888530368788885303 | 30 CAPSULE in 1 BOTTLE, PLASTIC (68788-8853-3)Marketed from Mar 24, 2025 |
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 — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 061837
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 68788-8853_4202cbfb-52e9-47f2-bd3a-1003319ca3cbSPL ID 4202cbfb-52e9-47f2-bd3a-1003319ca3cbSPL set ID 4202cbfb-52e9-47f2-bd3a-1003319ca3cbRxCUI 198252UNII 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
N468788885303followed by a unit qualifier and the quantityPackage 68788-8853-03. 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 capsules and other antibacterial drugs, tetracycline hydrochloride capsules should be used only to treat or prevent 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 desig…
Excerpt only. Read the full label for complete information.
About NDC 68788-8853
- What is NDC 68788-8853?
- 68788-8853 is the product NDC for Tetracycline Hydrochloride, Tetracycline hydrochloride 500 mg/1 capsule, listed with the FDA by Preferred Pharmaceuticals 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 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 500 mg/1 | Tablet, Film coatedOral | Pharmaka Generics Inc. | 82644-870 | 82644-0870-60 |
| 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 061837
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 | Actavis Pharma, Inc. | 0591-2474 |