Prescription drug · ANDA
Doxycycline NDC 64380-208
Doxycycline 150 mg/1 · Tablet · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-208-01 | 64380020801 | 30 TABLET in 1 BOTTLE (64380-208-01)Marketed from Sep 19, 2022 |
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
- Generic name (nonproprietary)
- doxycycline
- Active ingredients
- Doxycycline — 150 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Strides Pharma Science LimitedNDC labeler code 64380
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065070
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 64380-208_27575633-ff92-45c4-a365-510f656d68dcSPL ID 27575633-ff92-45c4-a365-510f656d68dcSPL set ID 3b9888a2-ca16-43f7-ab6d-f03188ec2c0dRxCUI 1649429, 1650142, 1650444, 1652673UNII N12000U13OUPC 0364380207016, 0364380205012, 0364380208013, 0364380206019
- 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
N464380020801followed by a unit qualifier and the quantityPackage 64380-0208-01. 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 effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline 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. Doxycycline is indicated for the treatment of the following infections: Rocky mountain spotted fever, typhus fever and the typhus group…
Excerpt only. Read the full label for complete information.
About NDC 64380-208
- What is NDC 64380-208?
- 64380-208 is the product NDC for Doxycycline, Doxycycline 150 mg/1 tablet, listed with the FDA by Strides Pharma Science Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Doxycycline.
- What is the active ingredient?
- Doxycycline.
- Who is the labeler?
- Strides Pharma Science Limited, NDC labeler code 64380. 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?
- 135 other product NDCs are listed under this name. See all Doxycycline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Doxycycline 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 | Doxycycline 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4762 | 70518-4762-00 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-159 | 48433-0159-03 |
| doxycycline | Doxycycline 50 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-158 | 48433-0158-03 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Coupler LLC | 67046-1260 | 67046-1260-03 |
| doxycycline | Doxycycline hyclate 100 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4176 | 68788-4176-0068788-4176-0168788-4176-02+3 more |
| doxycycline | Doxycycline hyclate 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4655 | 70518-4655-0070518-4655-01 |
| Doxycycline | Doxycycline hyclate 100 mg/100mg | Injection, Powder, Lyophilized, For solutionIntravenous | Steriscience Specialties Private Limited | 82449-008 | 82449-0008-02 |
| Doxycycline | Doxycycline 100 mg/1 | CapsuleOral | American Health Packaging | 60687-943 | 60687-0943-21 |
| Doxycycline | Doxycycline hyclate 100 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | JVET PHARMACEUTICALS LLC | 86211-116 | 86211-0116-10 |
| Doxycycline | Doxycycline 40 mg/1 | CapsuleOral | AiPing Pharmaceutical, Inc. | 11788-134 | 11788-0134-30 |
Other NDCs under ANDA 065070
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 |
|---|---|---|---|---|
| Doxycycline | Doxycycline 50 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-205 |
| Doxycycline | Doxycycline 75 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-206 |
| Doxycycline | Doxycycline 100 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-207 |