Prescription drug · ANDA
Doxycycline hyclate NDC 82804-316
Doxycycline hyclate 50 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-316-20 | 8280403162082804031620 | 20 CAPSULE in 1 BOTTLE (82804-316-20)Marketed from Sep 16, 2026 |
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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- 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 82804-316_b0686eca-8bef-4e0d-a160-7b2c265f1b44SPL ID b0686eca-8bef-4e0d-a160-7b2c265f1b44
- 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
N482804031620followed by a unit qualifier and the quantityPackage 82804-0316-20. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 82804-316
- What is NDC 82804-316?
- 82804-316 is the product NDC for Doxycycline hyclate, Doxycycline hyclate 50 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 1 package NDC, 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?
- Proficient Rx LP, NDC labeler code 82804. 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 100 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-813 |
| 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 100 mg/1 | CapsuleOral | Sportpharm LLC | 85766-033 |