What is NDC 0591-4550?

0591-4550 is the product NDC for Doxycycline Hyclate, Doxycycline hyclate 50 mg/1 tablet, delayed release, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 0591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Doxycycline Hyclate?

175 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Doxycycline Hyclate NDC 0591-4550 | National Drug Code

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	0059145502200591455022	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.NDC labeler code 0591
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)

About NDC 0591-4550

What is NDC 0591-4550?: 0591-4550 is the product NDC for Doxycycline Hyclate, Doxycycline hyclate 50 mg/1 tablet, delayed release, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Doxycycline Hyclate.
What is the active ingredient?: Doxycycline hyclate.
Who is the labeler?: Actavis Pharma, Inc., NDC labeler code 0591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Doxycycline Hyclate?: 175 other product NDCs are listed under this name. See all Doxycycline Hyclate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Doxycycline Hyclate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	Unit Dose Solutions, Inc.	87441-029	87441-0029-01
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	Coupler LLC	67046-0135	67046-0135-03
Doxycycline Hyclate	Doxycycline hyclate 50 mg/1	TabletOral	Strides Pharma Science Limited	64380-225	64380-0225-01
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	TabletOral	Strides Pharma Science Limited	64380-226	64380-0226-02
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4658	70518-4658-00
Doxycycline Hyclate	Doxycycline hyclate 50 mg/1	CapsuleOral	Zhejiang Yongtai Pharmaceutical Co., Ltd	69434-016	69434-0016-0369434-0016-06
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	Zhejiang Yongtai Pharmaceutical Co., Ltd	69434-017	69434-0017-0369434-0017-06
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	TabletOral	REMEDYREPACK INC.	70518-4544	70518-4544-00
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	Macleods Pharmaceuticals Limited	33342-386	33342-0386-0833342-0386-1233342-0386-15
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-392	33342-0392-0533342-0392-0833342-0392-11+2 more

All 176 Doxycycline Hyclate NDCs

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