Metformin Hydrochloride NDC 43063-544

NDC codes

FDA NDC Directory

Product NDC (as listed)43063-544Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43063-0544Add 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
43063-544-30	43063054430	30 TABLET in 1 BOTTLE, PLASTIC (43063-544-30)Marketed from Apr 3, 2014
43063-544-60	43063054460	60 TABLET in 1 BOTTLE, PLASTIC (43063-544-60)Marketed from Apr 3, 2014
43063-544-90	43063054490	90 TABLET in 1 BOTTLE, PLASTIC (43063-544-90)Marketed from Apr 3, 2014
43063-544-93	43063054493	180 TABLET in 1 BOTTLE, PLASTIC (43063-544-93)Marketed from Apr 3, 2014
43063-544-98	43063054498	120 TABLET in 1 BOTTLE, PLASTIC (43063-544-98)Marketed from Apr 3, 2014

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): Metformin Hydrochloride
Generic name (nonproprietary): metformin hydrochloride
Active ingredients: Metformin hydrochloride — 1000 mg/1
Dosage form: Tablet
Route: Oral
Labeler: PD-Rx Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077880
Marketing start: Dec 17, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 43063-544_413942f3-9d8b-ea87-e063-6394a90aeb7fSPL ID 413942f3-9d8b-ea87-e063-6394a90aeb7fSPL set ID c72cfd1a-dce9-43a3-88e2-3cf1d9078b52RxCUI 861004UNII 786Z46389EUPC 0343063544303
Pharmacologic class: Biguanide

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

N443063054430 followed by a unit qualifier and the quantity

Package 43063-0544-30. 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 077880

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

FDA NDC Directory listings under ANDA 077880
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-527
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-218
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-219
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-220