Prescription drug · NDA AUTHORIZED GENERIC
Dapagliflozin NDC 66993-457
Dapagliflozin propanediol 10 mg/1 · Tablet, Film coated · Oral · Prasco Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66993-457-30 | 6699304573066993045730 | 30 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
- 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
N466993045730followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Dapagliflozin products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under NDA 202293
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3253 |
| Dapagliflozin | Dapagliflozin propanediol 5 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-456 |
| 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 |