Prescription drug · ANDA
Doxycycline (Doxycycline hyclate) NDC 55289-866
Doxycycline hyclate 100 mg/1 · Tablet, Coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55289-866-01 | 5528908660155289086601 | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-01)Marketed from Jul 17, 2014 | |
| 55289-866-02 | 5528908660255289086602 | 2 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-02)Marketed from Jul 2, 2015 | |
| 55289-866-04 | 5528908660455289086604 | 4 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-04)Marketed from Mar 3, 2004 | |
| 55289-866-06 | 5528908660655289086606 | 6 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-06)Marketed from Dec 2, 2008 | |
| 55289-866-07 | 5528908660755289086607 | 7 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-07)Marketed from Sep 7, 2016 | |
| 55289-866-10 | 5528908661055289086610 | 10 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-10)Marketed from Dec 2, 2008 | |
| 55289-866-20 | 5528908662055289086620 | 20 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-20)Marketed from Jul 24, 2007 | |
| 55289-866-28 | 5528908662855289086628 | 28 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-28)Marketed from Dec 2, 2008 | |
| 55289-866-30 | 5528908663055289086630 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-30)Marketed from Dec 29, 2008 | |
| 55289-866-50 | 5528908665055289086650 | 50 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-50)Marketed from Dec 26, 2024 | |
| 55289-866-60 | 5528908666055289086660 | 60 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-60)Marketed from Dec 2, 2008 | |
| 55289-866-71 | 5528908667155289086671 | 210 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-71)Marketed from Dec 22, 2008 | |
| 55289-866-74 | 5528908667455289086674 | 400 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-74)Marketed from Dec 2, 2008 | |
| 55289-866-82 | 5528908668255289086682 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-82)Marketed from Dec 26, 2024 | |
| 55289-866-85 | 5528908668555289086685 | 330 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-85)Marketed from Dec 2, 2008 | |
| 55289-866-86 | 5528908668655289086686 | 360 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-86)Marketed from Dec 2, 2008 | |
| 55289-866-87 | 5528908668755289086687 | 300 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-87)Marketed from Dec 2, 2008 | |
| 55289-866-90 | 5528908669055289086690 | 90 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-90)Marketed from Dec 29, 2008 | |
| 55289-866-93 | 5528908669355289086693 | 180 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-93)Marketed from Dec 29, 2008 | |
| 55289-866-95 | 5528908669555289086695 | 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-95)Marketed from Dec 26, 2024 | |
| 55289-866-98 | 5528908669855289086698 | 120 TABLET, COATED in 1 BOTTLE, PLASTIC (55289-866-98)Marketed from Jul 17, 2014 |
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 hyclate
- Active ingredients
- Doxycycline hyclate — 100 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 55289
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065095
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 55289-866_5412f4e5-3c49-be12-e063-6394a90ac00aSPL ID 5412f4e5-3c49-be12-e063-6394a90ac00aSPL set ID c96d3986-9d92-4ec4-a319-a50aeb2f4fe7RxCUI 1650143UNII 19XTS3T51UUPC 0355289866954
- 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
N455289086601followed by a unit qualifier and the quantityPackage 55289-0866-01. 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 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 55289-866
- What is NDC 55289-866?
- 55289-866 is the product NDC for Doxycycline (doxycycline hyclate), Doxycycline hyclate 100 mg/1 tablet, coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 21 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Doxycycline (Doxycycline Hyclate).
- What is the active ingredient?
- Doxycycline hyclate.
- Who is the labeler?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 55289. 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 065095
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 |
|---|---|---|---|---|
| Doxycyclinedoxycycline hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | REMEDYREPACK INC. | 70518-3039 |
| Doxycyclinedoxycycline hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | Cardinal Health 107, LLC | 55154-7128 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | Northwind Health Company, LLC | 51655-998 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | Cardinal Health 107, LLC | 55154-8079 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | Major Pharmaceuticals | 0904-0430 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | QPharma, Inc. | 42708-173 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | A-S Medication Solutions | 50090-7580 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | Hikma Pharmaceuticals USA Inc. | 0143-2112 |
| Doxycycline Hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | American Health Packaging | 62584-693 |