NDC codes

FDA NDC Directory
Product NDC (as listed)66993-457Labeler and product segments. Claims need a package NDC.
Product NDC at billing width66993-0457Add 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
66993-457-30669930457306699304573030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (66993-457-30)Marketed from Jan 3, 2024

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 propanediol — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Prasco LaboratoriesNDC labeler code 66993
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 202293
Marketing start
Listing expires
Other FDA classes
Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
Identifiers
Product ID 66993-457_10840285-52f3-4d61-800d-6e280488650eSPL ID 10840285-52f3-4d61-800d-6e280488650eSPL set ID 3aba33aa-f8c6-4b10-85c8-dfa14578d07cRxCUI 1488569, 1488574UNII 887K2391VH

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

N466993045730 followed by a unit qualifier and the quantity

Package 66993-0457-30. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

DAPAGLIFLOZIN TABLETS are indicated: • To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. • To reduce the risk of CV 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 CV disease or multiple CV 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 diabetes mellitus. Limitations of Use…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 66993-457

What is NDC 66993-457?
66993-457 is the product NDC for Dapagliflozin, Dapagliflozin propanediol 10 mg/1 tablet, film coated, listed with the FDA by Prasco Laboratories. 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?
Prasco Laboratories, NDC labeler code 66993. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DapagliflozinDapagliflozin 5 mg/1TabletOralMicro Labs Limited42571-31742571-0317-1042571-0317-3042571-0317-90
DapagliflozinDapagliflozin 10 mg/1TabletOralMicro Labs Limited42571-31842571-0318-1042571-0318-3042571-0318-90
DapagliflozinDapagliflozin 5 mg/1Tablet, Film coatedOralAvKARE73190-07273190-0072-3073190-0072-90
DapagliflozinDapagliflozin 10 mg/1Tablet, Film coatedOralAvKARE73190-07373190-0073-3073190-0073-90
DapagliflozinDapagliflozin 5 mg/1Tablet, Film coatedOralANI Pharmaceuticals, Inc.70954-85670954-0856-10
DapagliflozinDapagliflozin 10 mg/1Tablet, Film coatedOralANI Pharmaceuticals, Inc.70954-85770954-0857-10
DapagliflozinDapagliflozin 2,3-butanediol monohydrate 5 mg/1Tablet, Film coatedOralBiocon Pharma Inc.70377-02370377-0023-1170377-0023-12
DapagliflozinDapagliflozin 2,3-butanediol monohydrate 10 mg/1Tablet, Film coatedOralBiocon Pharma Inc.70377-02470377-0024-1170377-0024-12
DapagliflozinDapagliflozin 5 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-352700480-3527-0500480-3527-5600480-3527-98
DapagliflozinDapagliflozin 10 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-352800480-3528-0500480-3528-5600480-3528-98

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
ProductStrengthForm · routeLabelerProduct NDC
DapagliflozinDapagliflozin propanediol 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7056
DapagliflozinDapagliflozin propanediol 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7057
DapagliflozinDapagliflozin propanediol 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-3253
DapagliflozinDapagliflozin propanediol 5 mg/1Tablet, Film coatedOralPrasco Laboratories66993-456
FarxigadapagliflozinDapagliflozin propanediol 5 mg/1Tablet, Film coatedOralAstraZeneca Pharmaceuticals LP0310-6205
FarxigadapagliflozinDapagliflozin propanediol 10 mg/1Tablet, Film coatedOralAstraZeneca Pharmaceuticals LP0310-6210
FarxigadapagliflozinDapagliflozin propanediol 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3481
FarxigadapagliflozinDapagliflozin propanediol 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3482
FarxigadapagliflozinDapagliflozin propanediol 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4614

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