Prescription drug · ANDA
Doxycycline Hyclate NDC 53489-647
Doxycycline hyclate 20 mg/1 · Tablet, Film coated · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53489-647-01 | 53489064701 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-01)Marketed from May 13, 2005 | |
| 53489-647-03 | 53489064703 | 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-03)Marketed from May 13, 2005 | |
| 53489-647-05 | 53489064705 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-05)Marketed from May 13, 2005 | |
| 53489-647-06 | 53489064706 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-06)Marketed from May 13, 2005 | |
| 53489-647-07 | 53489064707 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-07)Marketed from May 13, 2005 | |
| 53489-647-10 | 53489064710 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-10)Marketed from May 13, 2005 | |
| 53489-647-90 | 53489064790 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-90)Marketed from May 13, 2005 |
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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 53489
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065134
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 53489-647_31dd6775-5a9a-9e21-e063-6294a90aa546SPL ID 31dd6775-5a9a-9e21-e063-6294a90aa546SPL set ID bff3f426-44fc-4dbf-96df-df44011103e8RxCUI 283535UNII 19XTS3T51UUPC 0353489647014
- 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
N453489064701followed by a unit qualifier and the quantityPackage 53489-0647-01. 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 Doxycycline hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.
Excerpt only. Read the full label for complete information.
About NDC 53489-647
- What is NDC 53489-647?
- 53489-647 is the product NDC for Doxycycline Hyclate, Doxycycline hyclate 20 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 7 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?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 53489. 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 | TabletOral | Macleods Pharmaceuticals Limited | 33342-392 | 33342-0392-0533342-0392-0833342-0392-11+2 more |
Other NDCs under ANDA 065134
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 Hyclate | Doxycycline hyclate 20 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-309 |