What is NDC 80425-0319?

80425-0319 is the product NDC for Doxycycline Monohydrate, Doxycycline 100 mg/1 tablet, film coated, 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 Monohydrate?

6 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Doxycycline Monohydrate NDC 80425-0319

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0319Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0319Add 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
80425-0319-1	8042503190180425031901	30 TABLET, FILM COATED in 1 BOTTLE (80425-0319-1)Marketed from Apr 11, 2023
80425-0319-2	8042503190280425031902	60 TABLET, FILM COATED in 1 BOTTLE (80425-0319-2)Marketed from Apr 11, 2023
80425-0319-3	8042503190380425031903	90 TABLET, FILM COATED in 1 BOTTLE (80425-0319-3)Marketed from Apr 11, 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 Monohydrate
Generic name (nonproprietary): doxycycline monohydrate
Active ingredients: Doxycycline — 100 mg/1
Dosage form: Tablet, Film coated
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 209582
Marketing start: Apr 11, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Tetracyclines (Chemical structure)
Identifiers: Product ID 80425-0319_2a9bf7d3-46da-0dfa-e063-6394a90a76a4SPL ID 2a9bf7d3-46da-0dfa-e063-6394a90a76a4SPL set ID f91373f2-c57b-f1f1-e053-6294a90a7bddRxCUI 1650142UNII N12000U13O
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

N480425031901 followed by a unit qualifier and the quantity

Package 80425-0319-01. 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)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline tablets 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. Doxycycline is indicated for the treatment of the following infections: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickett…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0319

What is NDC 80425-0319?: 80425-0319 is the product NDC for Doxycycline Monohydrate, Doxycycline 100 mg/1 tablet, film coated, 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 Monohydrate.
What is the active ingredient?: Doxycycline.
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 Monohydrate?: 6 other product NDCs are listed under this name. See all Doxycycline Monohydrate 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 Monohydrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Doxycycline Monohydrate	Doxycycline 100 mg/1	CapsuleOral	Direct_Rx	72189-358	72189-0358-20
Doxycycline Monohydrate	Doxycycline 100 mg/1	CapsuleOral	DIRECT RX	61919-624	61919-0624-1461919-0624-2061919-0624-30
Doxycycline Monohydrate	Doxycycline 50 mg/1	CapsuleOral	Chartwell RX, LLC.	62135-260	62135-0260-01
Doxycycline Monohydrate	Doxycycline 75 mg/1	CapsuleOral	Chartwell RX, LLC.	62135-261	62135-0261-01
Doxycycline Monohydrate	Doxycycline 100 mg/1	CapsuleOral	Chartwell RX, LLC.	62135-262	62135-0262-2062135-0262-2562135-0262-50+1 more
Doxycycline Monohydrate	Doxycycline 150 mg/1	CapsuleOral	Chartwell RX, LLC.	62135-263	62135-0263-60

Other NDCs under ANDA 209582

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

FDA NDC Directory listings under ANDA 209582
Product	Strength	Form · route	Labeler	Product NDC
Doxycycline	Doxycycline 50 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1006
Doxycycline	Doxycycline 75 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1007
Doxycycline	Doxycycline 100 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1008
Doxycycline	Doxycycline 150 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	70771-1009
Doxycycline	Doxycycline 100 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1123
Doxycycline	Doxycycline 50 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1121
Doxycycline	Doxycycline 75 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1122
Doxycycline	Doxycycline 150 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	70710-1124
Doxycycline	Doxycycline 100 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2638
Doxycycline	Doxycycline 100 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3809
Doxycycline	Doxycycline 100 mg/1	Tablet, Film coatedOral	Proficient Rx LP	82804-028