Prescription drug · ANDA
Doxycycline Hyclate NDC 33342-392
Doxycycline hyclate 100 mg/1 · Tablet · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-392-05 | 33342039205 | 20 TABLET in 1 BOTTLE (33342-392-05)Marketed from Nov 19, 2025 | |
| 33342-392-08 | 33342039208 | 50 TABLET in 1 BOTTLE (33342-392-08)Marketed from Nov 19, 2025 | |
| 33342-392-11 | 33342039211 | 100 TABLET in 1 BOTTLE (33342-392-11)Marketed from Nov 19, 2025 | |
| 33342-392-12 | 33342039212 | 10 BLISTER PACK in 1 CARTON (33342-392-12) / 10 TABLET in 1 BLISTER PACKMarketed from Nov 19, 2025 | |
| 33342-392-15 | 33342039215 | 500 TABLET in 1 BOTTLE (33342-392-15)Marketed from Nov 19, 2025 |
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)
- Doxycycline Hyclate
- Generic name (nonproprietary)
- doxycycline hyclate
- Active ingredients
- Doxycycline hyclate — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Macleods Pharmaceuticals LimitedNDC labeler code 33342
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211418
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 33342-392_2696f799-7902-4239-807a-9ae85a5d0f1dSPL ID 2696f799-7902-4239-807a-9ae85a5d0f1dSPL set ID 2696f799-7902-4239-807a-9ae85a5d0f1dRxCUI 1650143UNII 19XTS3T51UUPC 0333342392114, 0333342392084, 0333342392152, 0333342392053
- Pharmacologic class
- Tetracycline-class Drug
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
N433342039205followed by a unit qualifier and the quantityPackage 33342-0392-05. 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 & USAGE To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets 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. Treatment: Doxycycline is indicated for the treatment of the following infections: • Rocky Mountain spotted fever, typhus…
Excerpt only. Read the full label for complete information.
About NDC 33342-392
- What is NDC 33342-392?
- 33342-392 is the product NDC for Doxycycline Hyclate, Doxycycline hyclate 100 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Doxycycline Hyclate.
- What is the active ingredient?
- Doxycycline hyclate.
- Who is the labeler?
- Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Doxycycline Hyclate?
- 174 other product NDCs are listed under this name. See all Doxycycline Hyclate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Doxycycline Hyclate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | Unit Dose Solutions, Inc. | 87441-029 | 87441-0029-01 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | Coupler LLC | 67046-0135 | 67046-0135-03 |
| Doxycycline Hyclate | Doxycycline hyclate 50 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-225 | 64380-0225-01 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-226 | 64380-0226-02 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4658 | 70518-4658-00 |
| Doxycycline Hyclate | Doxycycline hyclate 50 mg/1 | CapsuleOral | Zhejiang Yongtai Pharmaceutical Co., Ltd | 69434-016 | 69434-0016-0369434-0016-06 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | Zhejiang Yongtai Pharmaceutical Co., Ltd | 69434-017 | 69434-0017-0369434-0017-06 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4544 | 70518-4544-00 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-386 | 33342-0386-0833342-0386-1233342-0386-15 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4510 | 70518-4510-00 |