Doxycycline Hyclate NDC 53489-647

NDC codes

FDA NDC Directory

Product NDC (as listed)53489-647Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53489-0647Add 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
53489-647-01	53489064701	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-01)Marketed from May 13, 2005
53489-647-03	53489064703	250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-03)Marketed from May 13, 2005
53489-647-05	53489064705	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-05)Marketed from May 13, 2005
53489-647-06	53489064706	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-06)Marketed from May 13, 2005
53489-647-07	53489064707	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-07)Marketed from May 13, 2005
53489-647-10	53489064710	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-10)Marketed from May 13, 2005
53489-647-90	53489064790	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-647-90)Marketed from May 13, 2005

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 — 20 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 065134
Marketing start: May 13, 2005
Listing expires: Dec 31, 2026
Other FDA classes: Tetracyclines (Chemical structure)
Identifiers: Product ID 53489-647_31dd6775-5a9a-9e21-e063-6294a90aa546SPL ID 31dd6775-5a9a-9e21-e063-6294a90aa546SPL set ID bff3f426-44fc-4dbf-96df-df44011103e8RxCUI 283535UNII 19XTS3T51UUPC 0353489647014
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

N453489064701 followed by a unit qualifier and the quantity

Package 53489-0647-01. 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 Apr 3, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Doxycycline hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065134

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

FDA NDC Directory listings under ANDA 065134
Product	Strength	Form · route	Labeler	Product NDC
Doxycycline Hyclate	Doxycycline hyclate 20 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-309