What is NDC 42571-318?

42571-318 is the product NDC for Dapagliflozin, Dapagliflozin 10 mg/1 tablet, listed with the FDA by Micro Labs Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dapagliflozin?

46 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dapagliflozin NDC 42571-318 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-318Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0318Add 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
42571-318-10	42571031810	1000 TABLET in 1 BOTTLE (42571-318-10)Marketed from Oct 1, 2026
42571-318-30	42571031830	30 TABLET in 1 BOTTLE (42571-318-30)Marketed from Oct 1, 2026
42571-318-90	42571031890	90 TABLET in 1 BOTTLE (42571-318-90)Marketed from Oct 1, 2026

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): Dapagliflozin
Generic name (nonproprietary): dapagliflozin
Active ingredients: Dapagliflozin — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Micro Labs LimitedNDC labeler code 42571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211467
Marketing start: Oct 1, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 42571-318_4eee1c9a-00d2-3d23-e063-6294a90a72cdSPL ID 4eee1c9a-00d2-3d23-e063-6294a90a72cd
Pharmacologic class: Sodium-Glucose Cotransporter 2 Inhibitor

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

N442571031810 followed by a unit qualifier and the quantity

Package 42571-0318-10. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 42571-318

What is NDC 42571-318?: 42571-318 is the product NDC for Dapagliflozin, Dapagliflozin 10 mg/1 tablet, listed with the FDA by Micro Labs Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dapagliflozin.
What is the active ingredient?: Dapagliflozin.
Who is the labeler?: Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dapagliflozin?: 46 other product NDCs are listed under this name. See all Dapagliflozin 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 Dapagliflozin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dapagliflozin	Dapagliflozin 5 mg/1	TabletOral	Micro Labs Limited	42571-317	42571-0317-1042571-0317-3042571-0317-90
Dapagliflozin	Dapagliflozin 5 mg/1	Tablet, Film coatedOral	AvKARE	73190-072	73190-0072-3073190-0072-90
Dapagliflozin	Dapagliflozin 10 mg/1	Tablet, Film coatedOral	AvKARE	73190-073	73190-0073-3073190-0073-90
Dapagliflozin	Dapagliflozin 5 mg/1	Tablet, Film coatedOral	ANI Pharmaceuticals, Inc.	70954-856	70954-0856-10
Dapagliflozin	Dapagliflozin 10 mg/1	Tablet, Film coatedOral	ANI Pharmaceuticals, Inc.	70954-857	70954-0857-10
Dapagliflozin	Dapagliflozin 2,3-butanediol monohydrate 5 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc.	70377-023	70377-0023-1170377-0023-12
Dapagliflozin	Dapagliflozin 2,3-butanediol monohydrate 10 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc.	70377-024	70377-0024-1170377-0024-12
Dapagliflozin	Dapagliflozin 5 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-3527	00480-3527-0500480-3527-5600480-3527-98
Dapagliflozin	Dapagliflozin 10 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-3528	00480-3528-0500480-3528-5600480-3528-98
Dapagliflozin	Dapagliflozin 5 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-4911	60505-4911-03

All 47 Dapagliflozin NDCs

Other NDCs under ANDA 211467

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

FDA NDC Directory listings under ANDA 211467
Product	Strength	Form · route	Labeler	Product NDC
Dapagliflozin	Dapagliflozin 5 mg/1	TabletOral	Micro Labs Limited	42571-317