Doxycycline (doxycycline hyclate) NDC 42192-501

NDC codes

FDA NDC Directory

Product NDC (as listed)42192-501Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42192-0501Add 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	Copy
42192-501-05	42192050105	500 TABLET, COATED in 1 BOTTLE (42192-501-05)Marketed from Aug 21, 2020
42192-501-50	42192050150	50 TABLET, COATED in 1 BOTTLE (42192-501-50)Marketed from Aug 21, 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
Generic name (nonproprietary): doxycycline hyclate
Active ingredients: Doxycycline hyclate — 100 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Acella Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210664
Marketing start: Aug 21, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Tetracyclines (Chemical structure)
Identifiers: Product ID 42192-501_5957035d-19d3-b251-e063-6394a90a0561SPL ID 5957035d-19d3-b251-e063-6394a90a0561SPL set ID 3fb9f5ad-90a2-4858-bc34-f800d8b2fa90RxCUI 1650143UNII 19XTS3T51UUPC 0342192501058
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

N442192050105 followed by a unit qualifier and the quantity

Package 42192-0501-05. 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 18, 2026.

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 is indicated for the treatment of the following infections: Rocky Mountain spotted fever, typhus…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210664

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

FDA NDC Directory listings under ANDA 210664
Product	Strength	Form · route	Labeler	Product NDC
Doxycyclinedoxycycline hyclate	Doxycycline hyclate 100 mg/1	Tablet, CoatedOral	REMEDYREPACK INC.	70518-3363