Prescription drug · ANDA
doxycycline NDC 68999-417
Doxycycline 25 mg/5mL · Powder, For suspension · Oral · Chartwell Governmental & Specialty RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68999-417-46 | 6899904174668999041746 | 60 mL in 1 BOTTLE, GLASS (68999-417-46)Marketed from Sep 1, 2021 |
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 — 25 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Chartwell Governmental & Specialty RX, LLCNDC labeler code 68999
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065454
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 68999-417_40076faf-09c3-f4ab-e063-6394a90ab3c1SPL ID 40076faf-09c3-f4ab-e063-6394a90ab3c1SPL set ID b8486639-7eb9-4610-9cd4-0e922045d592RxCUI 1649405, 1649988, 1650030, 1650143, 1652674UNII N12000U13O, 19XTS3T51UUPC 0368999626404, 0368999626282, 0368999625605, 0368999985501, 0368999984504, 0368999417460, 0368999626305, 0368999626060, 0368999626312, 0368999626503
- 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
N468999041746followed by a unit qualifier and the quantityPackage 68999-0417-46. 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 and other antibacterial drugs, doxycycline 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 fever and the typhus group, Q fev…
Excerpt only. Read the full label for complete information.
About NDC 68999-417
- What is NDC 68999-417?
- 68999-417 is the product NDC for doxycycline, Doxycycline 25 mg/5mL powder, for suspension, listed with the FDA by Chartwell Governmental & Specialty RX, LLC. 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?
- Chartwell Governmental & Specialty RX, LLC, NDC labeler code 68999. 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?
- 136 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 065454
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 25 mg/5mL | Powder, For suspensionOral | Chartwell RX LLC | 62135-417 |
| doxycycline | Doxycycline 25 mg/5mL | Powder, For suspensionOral | Chartwell RX LLC | 62135-877 |