What is NDC 80425-0280?

80425-0280 is the product NDC for Doxycycline Hyclate, Doxycycline hyclate 100 mg/1 capsule, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 80425-0280

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0280Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0280Add 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
80425-0280-1	8042502800180425028001	10 CAPSULE in 1 BOTTLE (80425-0280-1)Marketed from Mar 2, 2023
80425-0280-2	8042502800280425028002	20 CAPSULE in 1 BOTTLE (80425-0280-2)Marketed from Mar 2, 2023
80425-0280-3	8042502800380425028003	14 CAPSULE in 1 BOTTLE (80425-0280-3)Marketed from Jun 9, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 062676
Marketing start: Mar 2, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Tetracyclines (Chemical structure)
Identifiers: Product ID 80425-0280_2a9bf621-afb9-7627-e063-6294a90a77a9SPL ID 2a9bf621-afb9-7627-e063-6294a90a77a9SPL set ID f5ed9293-15f8-ecfa-e053-2a95a90ab6a4RxCUI 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

N480425028001 followed by a unit qualifier and the quantity

Package 80425-0280-01. 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 Dec 31, 2024.

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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0280

What is NDC 80425-0280?: 80425-0280 is the product NDC for Doxycycline Hyclate, Doxycycline hyclate 100 mg/1 capsule, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 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?: Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 062676

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

FDA NDC Directory listings under ANDA 062676
Product	Strength	Form · route	Labeler	Product NDC
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	Quality Care Products, LLC	49999-126
Doxycycline Hyclate	Doxycycline hyclate 50 mg/1	CapsuleOral	AvPAK	50268-277
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	AvPAK	50268-278
Doxycycline Hyclate	Doxycycline hyclate 50 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	53489-118
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	Sun Pharmaceutical Industries, Inc.	53489-119
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	DIRECT RX	61919-082
Doxycycline Hyclate	Doxycycline hyclate 50 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-3564
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-1248
Doxycycline Hyclate	Doxycycline hyclate 50 mg/1	CapsuleOral	Proficient Rx LP	71205-653
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-277
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-298
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	72789-369
Doxycycline Hyclate	Doxycycline hyclate 100 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0211