What is NDC 70377-023?

70377-023 is the product NDC for Dapagliflozin, Dapagliflozin 2,3-butanediol monohydrate 5 mg/1 tablet, film coated, listed with the FDA by Biocon Pharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Dapagliflozin 2,3-butanediol monohydrate.

Biocon Pharma Inc., NDC labeler code 70377. 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 70377-023 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70377-023Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70377-0023Add 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	Copy
70377-023-11	7037700231170377002311	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-023-11)Marketed from May 1, 2026
70377-023-12	7037700231270377002312	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-023-12)Marketed from May 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 2,3-butanediol monohydrate — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Biocon Pharma Inc.NDC labeler code 70377
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211470
Marketing start: May 1, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 70377-023_f23d20a0-8e57-6f45-e23b-0fffcb2f8652SPL ID f23d20a0-8e57-6f45-e23b-0fffcb2f8652SPL set ID 828f1004-3647-9a13-8008-c4b3759ecfd0RxCUI 1488569, 1488574UNII U289305BKGUPC 0370377024115, 0370377023118
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

N470377002311 followed by a unit qualifier and the quantity

Package 70377-0023-11. 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 Aug 21, 2026.

Indications (excerpt from the label)

Dapagliflozin tablets are indicated: To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established CV disease or multiple CV risk factors. As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1) ] . Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . Dapagliflozin tablets are likely to be ineffective in thi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70377-023

What is NDC 70377-023?: 70377-023 is the product NDC for Dapagliflozin, Dapagliflozin 2,3-butanediol monohydrate 5 mg/1 tablet, film coated, listed with the FDA by Biocon Pharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dapagliflozin.
What is the active ingredient?: Dapagliflozin 2,3-butanediol monohydrate.
Who is the labeler?: Biocon Pharma Inc., NDC labeler code 70377. 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 10 mg/1	TabletOral	Micro Labs Limited	42571-318	42571-0318-1042571-0318-3042571-0318-90
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 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 211470

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

FDA NDC Directory listings under ANDA 211470
Product	Strength	Form · route	Labeler	Product NDC
Dapagliflozin	Dapagliflozin 2,3-butanediol monohydrate 10 mg/1	Tablet, Film coatedOral	Biocon Pharma Inc.	70377-024