Prescription drug · ANDA
Doxycycline (Doxycycline hyclate) NDC 72789-597
Doxycycline hyclate 100 mg/1 · Tablet, Coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-597-01 | 7278905970172789059701 | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-597-01)Marketed from Oct 6, 2026 | |
| 72789-597-06 | 7278905970672789059706 | 6 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-597-06)Marketed from Oct 6, 2026 | |
| 72789-597-10 | 7278905971072789059710 | 10 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-597-10)Marketed from Oct 6, 2026 | |
| 72789-597-14 | 7278905971472789059714 | 14 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-597-14)Marketed from Oct 6, 2026 | |
| 72789-597-20 | 7278905972072789059720 | 20 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-597-20)Marketed from Oct 6, 2026 | |
| 72789-597-28 | 7278905972872789059728 | 28 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-597-28)Marketed from Oct 6, 2026 | |
| 72789-597-30 | 7278905973072789059730 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-597-30)Marketed from Oct 6, 2026 | |
| 72789-597-50 | 7278905975072789059750 | 50 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-597-50)Marketed from Oct 6, 2026 | |
| 72789-597-60 | 7278905976072789059760 | 60 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-597-60)Marketed from Oct 6, 2026 | |
| 72789-597-71 | 7278905977172789059771 | 210 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-597-71)Marketed from Oct 6, 2026 | |
| 72789-597-74 | 7278905977472789059774 | 400 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-597-74)Marketed from Oct 6, 2026 | |
| 72789-597-82 | 7278905978272789059782 | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-597-82)Marketed from Oct 6, 2026 | |
| 72789-597-87 | 7278905978772789059787 | 300 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-597-87)Marketed from Oct 6, 2026 | |
| 72789-597-90 | 7278905979072789059790 | 90 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-597-90)Marketed from Oct 6, 2026 | |
| 72789-597-93 | 7278905979372789059793 | 180 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-597-93)Marketed from Oct 6, 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
- 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 72789
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210664
- Marketing start
- Listing expires
- Other FDA classes
- Tetracyclines (Chemical structure)
- Identifiers
- Product ID 72789-597_5d2ea6ea-e699-1cf6-e063-6294a90a564cSPL ID 5d2ea6ea-e699-1cf6-e063-6294a90a564c
- 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
N472789059701followed by a unit qualifier and the quantityPackage 72789-0597-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 72789-597
- What is NDC 72789-597?
- 72789-597 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 15 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 72789. 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 210664
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 | Acella Pharmaceuticals, LLC | 42192-501 |
| Doxycyclinedoxycycline hyclate | Doxycycline hyclate 100 mg/1 | Tablet, CoatedOral | REMEDYREPACK INC. | 70518-3363 |