What is NDC 63629-3253?

63629-3253 is the product NDC for Dapagliflozin, Dapagliflozin propanediol 10 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 63629. 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 63629-3253 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-3253Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-3253Add 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
63629-3253-1	6362932530163629325301	30 TABLET, FILM COATED in 1 BOTTLE (63629-3253-1)Marketed from Jan 24, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 propanediol — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 63629
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 202293
Marketing start: Jan 3, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 63629-3253_4ef8db0b-c28e-44ff-bf60-a9f8018c5861SPL ID 4ef8db0b-c28e-44ff-bf60-a9f8018c5861SPL set ID 979205ee-b0b8-4483-ae61-f283f750bb7fRxCUI 1488569UNII 887K2391VH
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

N463629325301 followed by a unit qualifier and the quantity

Package 63629-3253-01. 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

Current FDA label (SPL), effective Aug 8, 2024.

Indications (excerpt from the label)

DAPAGLIFLOZIN TABLETS are indicated: • To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. • To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure. • To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. • As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabet…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-3253

What is NDC 63629-3253?: 63629-3253 is the product NDC for Dapagliflozin, Dapagliflozin propanediol 10 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dapagliflozin.
What is the active ingredient?: Dapagliflozin propanediol.
Who is the labeler?: Bryant Ranch Prepack, NDC labeler code 63629. 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 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

All 47 Dapagliflozin NDCs

Other NDCs under NDA 202293

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

FDA NDC Directory listings under NDA 202293
Product	Strength	Form · route	Labeler	Product NDC
Dapagliflozin	Dapagliflozin propanediol 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7056
Dapagliflozin	Dapagliflozin propanediol 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7057
Dapagliflozin	Dapagliflozin propanediol 5 mg/1	Tablet, Film coatedOral	Prasco Laboratories	66993-456
Dapagliflozin	Dapagliflozin propanediol 10 mg/1	Tablet, Film coatedOral	Prasco Laboratories	66993-457
Farxigadapagliflozin	Dapagliflozin propanediol 5 mg/1	Tablet, Film coatedOral	AstraZeneca Pharmaceuticals LP	0310-6205
Farxigadapagliflozin	Dapagliflozin propanediol 10 mg/1	Tablet, Film coatedOral	AstraZeneca Pharmaceuticals LP	0310-6210
Farxigadapagliflozin	Dapagliflozin propanediol 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3481
Farxigadapagliflozin	Dapagliflozin propanediol 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-3482
Farxigadapagliflozin	Dapagliflozin propanediol 5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4614