Prescription drug · ANDA
Doxycycline hyclate NDC 76420-813
Doxycycline hyclate 100 mg/1 · Capsule · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-813-00 | 7642008130076420081300 | 1000 CAPSULE in 1 BOTTLE (76420-813-00)Marketed from May 7, 2024 | |
| 76420-813-01 | 7642008130176420081301 | 100 CAPSULE in 1 BOTTLE (76420-813-01)Marketed from May 7, 2024 | |
| 76420-813-05 | 7642008130576420081305 | 500 CAPSULE in 1 BOTTLE (76420-813-05)Marketed from May 7, 2024 | |
| 76420-813-10 | 7642008131076420081310 | 10 CAPSULE in 1 BOTTLE (76420-813-10)Marketed from May 7, 2024 | |
| 76420-813-14 | 7642008131476420081314 | 14 CAPSULE in 1 BOTTLE (76420-813-14)Marketed from Feb 10, 2025 | |
| 76420-813-20 | 7642008132076420081320 | 20 CAPSULE in 1 BOTTLE (76420-813-20)Marketed from Mar 18, 2025 | |
| 76420-813-28 | 7642008132876420081328 | 28 CAPSULE in 1 BOTTLE (76420-813-28)Marketed from May 31, 2025 | |
| 76420-813-30 | 7642008133076420081330 | 30 CAPSULE in 1 BOTTLE (76420-813-30)Marketed from May 7, 2024 | |
| 76420-813-50 | 7642008135076420081350 | 50 CAPSULE in 1 BOTTLE (76420-813-50)Marketed from May 7, 2024 | |
| 76420-813-60 | 7642008136076420081360 | 60 CAPSULE in 1 BOTTLE (76420-813-60)Marketed from May 7, 2024 | |
| 76420-813-90 | 7642008139076420081390 | 90 CAPSULE in 1 BOTTLE (76420-813-90)Marketed from May 7, 2024 |
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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207774
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 76420-813_366a864f-98c6-7cf2-e063-6294a90a0268SPL ID 366a864f-98c6-7cf2-e063-6294a90a0268SPL set ID bed39bae-64c2-44b4-9c95-682ead4e6738RxCUI 1649405, 1649988UNII 19XTS3T51U
- 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
N476420081300followed by a unit qualifier and the quantityPackage 76420-0813-00. 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 and other antibacterial drugs, doxycycline hyclate capsules 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 a…
Excerpt only. Read the full label for complete information.
About NDC 76420-813
- What is NDC 76420-813?
- 76420-813 is the product NDC for Doxycycline hyclate, Doxycycline hyclate 100 mg/1 capsule, listed with the FDA by Asclemed USA, Inc.. It has 11 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?
- Asclemed USA, Inc., NDC labeler code 76420. 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 207774
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 50 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6212 |
| Doxycycline hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4150 |
| Doxycycline hyclate | Doxycycline hyclate 50 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1358 |
| Doxycycline hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | Zydus Lifesciences Limited | 70771-1359 |
| Doxycycline hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2086 |
| Doxycycline hyclate | Doxycycline hyclate 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2179 |
| Doxycycline hyclate | Doxycycline hyclate 50 mg/1 | CapsuleOral | Viona Pharmaceuticals Inc | 72578-054 |
| Doxycycline hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | Viona Pharmaceuticals Inc | 72578-055 |
| Doxycycline hyclate | Doxycycline hyclate 50 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-814 |
| Doxycycline hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | Proficient Rx LP | 82804-179 |
| Doxycycline hyclate | Doxycycline hyclate 50 mg/1 | CapsuleOral | Proficient Rx LP | 82804-316 |
| Doxycycline hyclate | Doxycycline hyclate 100 mg/1 | CapsuleOral | Sportpharm LLC | 85766-033 |