Doxycycline Hyclate NDC 0591-4550

NDC codes

FDA NDC Directory

Product NDC (as listed)0591-4550Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00591-4550Add 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
0591-4550-22	00591455022	120 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-4550-22)Marketed from Aug 14, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 50 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Actavis Pharma, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090134
Marketing start: Aug 14, 2019
Marketing end: Jun 30, 2027
Other FDA classes: Tetracyclines (Chemical structure)
Identifiers: Product ID 0591-4550_304ae0bb-5f05-4389-8952-5a99391b8047SPL ID 304ae0bb-5f05-4389-8952-5a99391b8047SPL set ID c2b08332-3256-4658-965a-ede3d973a388RxCUI 1423080, 1653433UNII 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

N400591455022 followed by a unit qualifier and the quantity

Package 00591-4550-22. 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 1, 2025.

Indications (excerpt from the label)

Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: Rickettsial infections ( 1.1 ) Sexually transmitted infections ( 1.2 ) Respiratory tract infections ( 1.3 ) Specific bacterial infections ( 1.4 ) Ophthalmic infections ( 1.5 ) Anthrax, including inhalational anthrax (post-exposure) ( 1.6 ) Alternative treatment for selected infections when penicillin is contraindicated ( 1.7 ) Adjunctive therapy in acute intestinal amebiasis and severe acne ( 1.8 ) Prophylaxis of malaria ( 1.9 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, doxycyclin…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090134

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

FDA NDC Directory listings under ANDA 090134
Product	Strength	Form · route	Labeler	Product NDC
Doxycycline Hyclate	Doxycycline hyclate 200 mg/1	Tablet, Delayed releaseOral	Actavis Pharma, Inc.	0591-4575