Doxycycline Hyclate NDC 53489-120

NDC codes

FDA NDC Directory

Product NDC (as listed)53489-120Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53489-0120Add 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
53489-120-01	53489012001	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-120-01)Marketed from Dec 5, 2023
53489-120-02	53489012002	50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-120-02)Marketed from Jul 10, 1986
53489-120-05	53489012005	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-120-05)Marketed from Jul 10, 1986

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, Film coated
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 062677
Marketing start: Jul 10, 1986
Listing expires: Dec 31, 2027
Other FDA classes: Tetracyclines (Chemical structure)
Identifiers: Product ID 53489-120_53577734-d479-e32b-e063-6394a90a7933SPL ID 53577734-d479-e32b-e063-6394a90a7933SPL set ID 214a9cfe-a522-4022-81d4-e59f447401feRxCUI 1649405, 1649988, 1650143UNII 19XTS3T51UUPC 0353489118026
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

N453489012001 followed by a unit qualifier and the quantity

Package 53489-0120-01. 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 Jun 3, 2026.

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 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 and the t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 062677

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

FDA NDC Directory listings under ANDA 062677
Product	Strength	Form · route	Labeler	Product NDC
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-276
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-319
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3213
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-419
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	Tablet, Film coatedOral	AvPAK	50268-279