Prescription drug · ANDA
Doxycycline NDC 68382-911
Doxycycline hyclate 200 mg/20mL · Injection, Powder, Lyophilized, For solution · Intravenous · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-911-01 | 68382091101 | 1 VIAL in 1 CARTON (68382-911-01) / 20 mL in 1 VIALMarketed from Feb 1, 2018 |
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 hyclate — 200 mg/20mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Zydus Pharmaceuticals USA Inc.NDC labeler code 68382
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207757
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 68382-911_b99072cd-f6d8-4d24-9014-f76e327dd6d3SPL ID b99072cd-f6d8-4d24-9014-f76e327dd6d3SPL set ID 7ce80f6e-3c0d-4978-b626-5fd3f3ff349eRxCUI 310027, 1998483UNII 19XTS3T51UUPC 0368382911018
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N468382091101followed by a unit qualifier and the quantityPackage 68382-0911-01. 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 To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline for injection and other antibacterial drugs, doxycycline for injection 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 in infections caused by the following microorganisms: Rickettsiae (Rocky Mountain spotted fever, typhus feve…
Excerpt only. Read the full label for complete information.
About NDC 68382-911
- What is NDC 68382-911?
- 68382-911 is the product NDC for Doxycycline, Doxycycline hyclate 200 mg/20mL injection, powder, lyophilized, for solution, listed with the FDA by Zydus Pharmaceuticals USA Inc.. 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 hyclate.
- Who is the labeler?
- Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 50 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-158 | 48433-0158-03 |
| doxycycline | Doxycycline 100 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-159 | 48433-0159-03 |
| 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 207757
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 hyclate 100 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Zydus Pharmaceuticals USA Inc. | 68382-910 |
| Doxycycline | Doxycycline hyclate 100 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Zydus Lifesciences Limited | 70771-1121 |
| Doxycycline | Doxycycline hyclate 200 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | Zydus Lifesciences Limited | 70771-1122 |