Doxycycline Hyclate NDC 72578-001

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-001Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0001Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
72578-001-01	72578000101	100 TABLET in 1 BOTTLE (72578-001-01)Marketed from Mar 14, 2019
72578-001-05	72578000105	500 TABLET in 1 BOTTLE (72578-001-05)Marketed from Mar 14, 2019
72578-001-10	72578000110	1000 TABLET in 1 BOTTLE (72578-001-10)Marketed from Mar 14, 2019
72578-001-18	72578000118	50 TABLET in 1 BOTTLE (72578-001-18)Marketed from Mar 14, 2019
72578-001-77	72578000177	10 BLISTER PACK in 1 CARTON (72578-001-77) / 10 TABLET in 1 BLISTER PACK (72578-001-30)Marketed from Mar 14, 2019

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: Tablet
Route: Oral
Labeler: Viona Pharmaceuticals Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207773
Marketing start: Mar 14, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Tetracyclines (Chemical structure)
Identifiers: Product ID 72578-001_6fd4ce71-429d-4bbb-a8e6-afd510319830SPL ID 6fd4ce71-429d-4bbb-a8e6-afd510319830SPL set ID 763997f0-b35c-43cb-a792-3e0bae589536RxCUI 1650143UNII 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

N472578000101 followed by a unit qualifier and the quantity

Package 72578-0001-01. 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 Aug 12, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets 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 hyclate tablets are indicated for the treatment of the following infections: Rocky Mountain spott…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207773

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 207773
Product	Strength	Form · route	Labeler	Product NDC
Doxycycline hyclate	Doxycycline hyclate 100 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1104
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-2113
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	TabletOral	RedPharm Drug, Inc.	67296-1431
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8529