Prescription drug · ANDA
Doxycycline Hyclate NDC 46708-387
Doxycycline hyclate 75 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-387-60 | 4670803876046708038760 | 60 TABLET, FILM COATED in 1 BOTTLE (46708-387-60)Marketed from Jun 30, 2020 | |
| 46708-387-91 | 4670803879146708038791 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-387-91)Marketed from Jun 30, 2020 |
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 — 75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211744
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 46708-387_8becf01f-63de-4cf3-881e-94d18fe9274cSPL ID 8becf01f-63de-4cf3-881e-94d18fe9274cSPL set ID 6e587d8d-1a82-4dfa-acea-88704d408f2fRxCUI 1649425, 1650446UNII 19XTS3T51UUPC 0346708387600
- 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
N446708038760followed by a unit qualifier and the quantityPackage 46708-0387-60. 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)
Doxycycline hyclate tablets are tetracycline class drugs indicated for: · Rickettsial infections (1.1) · Sexually transmitted infections (1.2) · Respiratory tract infections (1.3) · Specific bacterial infections (1.4) · Ophthalmic infections (1.5) · Anthrax, including inhalational anthrax (post-exposure) (1.6) · Alternative treatment for selected infections when penicillin is contraindicated (1.7) · Adjunctive therapy for acute intestinal amebiasis and severe acne (1.8) · Prophylaxis of malaria (1.9) To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only …
Excerpt only. Read the full label for complete information.
About NDC 46708-387
- What is NDC 46708-387?
- 46708-387 is the product NDC for Doxycycline Hyclate, Doxycycline hyclate 75 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 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?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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?
- 175 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 211744
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 150 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-388 |
| Doxycycline Hyclate | Doxycycline hyclate 75 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-387 |
| Doxycycline Hyclate | Doxycycline hyclate 150 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-388 |