NDC codes

FDA NDC Directory
Product NDC (as listed)43547-325Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0325Add 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 NDC11-digit (billing)PackageCopy
43547-325-06435470325064354703250660 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-325-06)Marketed from Nov 28, 2016
43547-325-104354703251043547032510100 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-325-10)Marketed from Nov 28, 2016
43547-325-504354703255043547032550500 TABLET, DELAYED RELEASE in 1 BOTTLE (43547-325-50)Marketed from Nov 28, 2016

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 — 200 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
Solco Healthcare US LLCNDC labeler code 43547
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207494
Marketing start
Listing expires
Other FDA classes
Tetracyclines (Chemical structure)
Identifiers
Product ID 43547-325_49c9be01-a1bf-48aa-8ef4-0584e8dcaac5SPL ID 49c9be01-a1bf-48aa-8ef4-0584e8dcaac5SPL set ID 0a18d4c7-9484-4d3e-b61b-e81fe63fefecRxCUI 799048, 1423080, 1653433UNII 19XTS3T51UUPC 0343547325060, 0343547324063, 0343547462123
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

N443547032506 followed by a unit qualifier and the quantity

Package 43547-0325-06. 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 .

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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43547-325

What is NDC 43547-325?
43547-325 is the product NDC for Doxycycline Hyclate, Doxycycline hyclate 200 mg/1 tablet, delayed release, listed with the FDA by Solco Healthcare US 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?
Solco Healthcare US LLC, NDC labeler code 43547. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Doxycycline HyclateDoxycycline hyclate 100 mg/1CapsuleOralUnit Dose Solutions, Inc.87441-02987441-0029-01
Doxycycline HyclateDoxycycline hyclate 100 mg/1CapsuleOralCoupler LLC67046-013567046-0135-03
Doxycycline HyclateDoxycycline hyclate 50 mg/1TabletOralStrides Pharma Science Limited64380-22564380-0225-01
Doxycycline HyclateDoxycycline hyclate 100 mg/1TabletOralStrides Pharma Science Limited64380-22664380-0226-02
Doxycycline HyclateDoxycycline hyclate 100 mg/1CapsuleOralREMEDYREPACK INC.70518-465870518-4658-00
Doxycycline HyclateDoxycycline hyclate 50 mg/1CapsuleOralZhejiang Yongtai Pharmaceutical Co., Ltd69434-01669434-0016-0369434-0016-06
Doxycycline HyclateDoxycycline hyclate 100 mg/1CapsuleOralZhejiang Yongtai Pharmaceutical Co., Ltd69434-01769434-0017-0369434-0017-06
Doxycycline HyclateDoxycycline hyclate 100 mg/1TabletOralREMEDYREPACK INC.70518-454470518-4544-00
Doxycycline HyclateDoxycycline hyclate 100 mg/1CapsuleOralMacleods Pharmaceuticals Limited33342-38633342-0386-0833342-0386-1233342-0386-15
Doxycycline HyclateDoxycycline hyclate 100 mg/1TabletOralMacleods Pharmaceuticals Limited33342-39233342-0392-0533342-0392-0833342-0392-11+2 more

All 176 Doxycycline Hyclate NDCs

Other NDCs under ANDA 207494

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

FDA NDC Directory listings under ANDA 207494
ProductStrengthForm · routeLabelerProduct NDC
Doxycycline HyclateDoxycycline hyclate 150 mg/1Tablet, Delayed releaseOralSolco Healthcare US LLC43547-324
Doxycycline HyclateDoxycycline hyclate 50 mg/1Tablet, Delayed releaseOralSolco Healthcare US LLC43547-462
Doxycycline HyclateDoxycycline hyclate 150 mg/1Tablet, Delayed releaseOralSonoma Pharmaceuticals, Inc.69668-515

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