NDC codes

FDA NDC Directory
Product NDC (as listed)63304-131Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63304-0131Add 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
63304-131-0163304013101100 TABLET, FILM COATED in 1 BOTTLE (63304-131-01)Marketed from Aug 6, 2018
63304-131-10633040131101000 TABLET, FILM COATED in 1 BOTTLE (63304-131-10)Marketed from Aug 6, 2018

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
Generic name (nonproprietary)
doxycycline
Active ingredients
Doxycycline — 75 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065356
Marketing start
Listing expires
Other FDA classes
Tetracyclines (Chemical structure)
Identifiers
Product ID 63304-131_fd417a50-69b5-40b4-89fd-58aea77ab547SPL ID fd417a50-69b5-40b4-89fd-58aea77ab547SPL set ID 8224b9c5-5c4b-4dda-bc58-47b6604c2884RxCUI 1649429, 1650142, 1650444, 1652673UNII N12000U13OUPC 0363304173307
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

N463304013101 followed by a unit qualifier and the quantity

Package 63304-0131-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 065356

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

FDA NDC Directory listings under ANDA 065356
ProductStrengthForm · routeLabelerProduct NDC
DoxycyclineDoxycycline 50 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries Inc.63304-130
DoxycyclineDoxycycline 100 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries Inc.63304-132
DoxycyclineDoxycycline 150 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries Inc.63304-173

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