What is NDC 72578-055?

72578-055 is the product NDC for Doxycycline hyclate, Doxycycline hyclate 100 mg/1 capsule, listed with the FDA by Viona Pharmaceuticals Inc. It has 5 package NDCs, shown above in 10- and 11-digit form.

Viona Pharmaceuticals Inc, NDC labeler code 72578. 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 72578-055 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-055Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0055Add 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
72578-055-01	7257800550172578005501	100 CAPSULE in 1 BOTTLE (72578-055-01)Marketed from Jan 10, 2022
72578-055-05	7257800550572578005505	500 CAPSULE in 1 BOTTLE (72578-055-05)Marketed from Jan 10, 2022
72578-055-10	7257800551072578005510	1000 CAPSULE in 1 BOTTLE (72578-055-10)Marketed from Jan 10, 2022
72578-055-18	7257800551872578005518	50 CAPSULE in 1 BOTTLE (72578-055-18)Marketed from Jan 10, 2022
72578-055-77	7257800557772578005577	10 BLISTER PACK in 1 CARTON (72578-055-77) / 10 CAPSULE in 1 BLISTER PACK (72578-055-30)Marketed from Jan 10, 2022

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: Capsule
Route: Oral
Labeler: Viona Pharmaceuticals IncNDC labeler code 72578
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207774
Marketing start: Jan 10, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Tetracyclines (Chemical structure)
Identifiers: Product ID 72578-055_ebe90bc1-d956-4813-9d89-16212c08966bSPL ID ebe90bc1-d956-4813-9d89-16212c08966bSPL set ID 51d245a3-ef51-474a-bc91-377d5f42dde3RxCUI 1649405, 1649988UNII 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

N472578005501 followed by a unit qualifier and the quantity

Package 72578-0055-01. 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 Aug 25, 2025.

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 capsules 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 a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72578-055

What is NDC 72578-055?: 72578-055 is the product NDC for Doxycycline hyclate, Doxycycline hyclate 100 mg/1 capsule, listed with the FDA by Viona Pharmaceuticals Inc. It has 5 package NDCs, 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?: Viona Pharmaceuticals Inc, NDC labeler code 72578. 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 207774

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

FDA NDC Directory listings under ANDA 207774
Product	Strength	Form · route	Labeler	Product NDC
Doxycycline hyclate	Doxycycline hyclate 50 mg/1	CapsuleOral	A-S Medication Solutions	50090-6212
Doxycycline hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4150
Doxycycline hyclate	Doxycycline hyclate 50 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1358
Doxycycline hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	Zydus Lifesciences Limited	70771-1359
Doxycycline hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2086
Doxycycline hyclate	Doxycycline hyclate 50 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2179
Doxycycline hyclate	Doxycycline hyclate 50 mg/1	CapsuleOral	Viona Pharmaceuticals Inc	72578-054
Doxycycline hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-813
Doxycycline hyclate	Doxycycline hyclate 50 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-814
Doxycycline hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	Proficient Rx LP	82804-179
Doxycycline hyclate	Doxycycline hyclate 50 mg/1	CapsuleOral	Proficient Rx LP	82804-316
Doxycycline hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	Sportpharm LLC	85766-033