dapagliflozin 5 MG Oral Tablet
- RxCUI
- 1488574
- RxNorm name
- dapagliflozin 5 MG Oral Tablet
- Display name
- Dapagliflozin (Oral Pill)
- Full name
- dapagliflozin 5 MG Oral Tablet
- Term type
- SCD
- Status
- Active
- Strength
- 5 mg
- Dose form
- Tab
- Route
- Oral Pill
- Updated
- 2026-08-18 06:18:14
RxNorm Status History#
- Status
- Active
- Source
- RXNORM
- Current
- YES
- Release start
- 032014
- Active start
- 032014
- Multiple ingredient
- NO
- Branded
- NO
Ingredients And Strength#
| Ingredient | Strength | Base | Basis of strength |
|---|---|---|---|
| dapagliflozin | 5 MG / 1 EACH | dapagliflozin | dapagliflozin |
Dose Form Concepts#
| Dose form | RxCUI |
|---|---|
| Oral Tablet | 317541 |
Derived Ingredient Concepts#
| Ingredient | RxCUI |
|---|---|
| dapagliflozin | 1488564 |
Source Vocabulary Codes#
FDA NDC Products And Packages#
| Package NDC | Product NDC | Name | Labeler | Application |
|---|---|---|---|---|
| 0480-3527-56 | 0480-3527 | DAPAGLIFLOZIN DAPAGLIFLOZIN | Teva Pharmaceuticals, Inc. | ANDA211541 |
| 0480-3527-98 | 0480-3527 | DAPAGLIFLOZIN DAPAGLIFLOZIN | Teva Pharmaceuticals, Inc. | ANDA211541 |
| 0781-5985-01 | 0781-5985 | Dapagliflozin Dapagliflozin | Sandoz Inc | ANDA211312 |
| 0781-5985-05 | 0781-5985 | Dapagliflozin Dapagliflozin | Sandoz Inc | ANDA211312 |
| 0781-5985-10 | 0781-5985 | Dapagliflozin Dapagliflozin | Sandoz Inc | ANDA211312 |
| 0781-5985-31 | 0781-5985 | Dapagliflozin Dapagliflozin | Sandoz Inc | ANDA211312 |
| 27241-151-01 | 27241-151 | Dapagliflozin Dapagliflozin | Ajanta Pharma USA Inc. | ANDA211482 |
| 33342-585-07 | 33342-585 | dapagliflozin dapagliflozin | Macleods Pharmaceuticals Limited | ANDA211506 |
| 33342-585-10 | 33342-585 | dapagliflozin dapagliflozin | Macleods Pharmaceuticals Limited | ANDA211506 |
| 33342-585-12 | 33342-585 | dapagliflozin dapagliflozin | Macleods Pharmaceuticals Limited | ANDA211506 |
| 46708-392-30 | 46708-392 | DAPAGLIFLOZIN DAPAGLIFLOZIN | Alembic Pharmaceuticals Limited | ANDA211560 |
| 46708-392-91 | 46708-392 | DAPAGLIFLOZIN DAPAGLIFLOZIN | Alembic Pharmaceuticals Limited | ANDA211560 |
| 50090-7056-0 | 50090-7056 | DAPAGLIFLOZIN DAPAGLIFLOZIN | A-S Medication Solutions | NDA202293 |
| 50090-7971-0 | 50090-7971 | Dapagliflozin Dapagliflozin | A-S Medication Solutions | ANDA211468 |
| 59651-159-30 | 59651-159 | Dapagliflozin Dapagliflozin | Aurobindo Pharma Limited | ANDA211468 |
| 59651-159-90 | 59651-159 | Dapagliflozin Dapagliflozin | Aurobindo Pharma Limited | ANDA211468 |
| 60505-4911-3 | 60505-4911 | Dapagliflozin DAPAGLIFLOZIN | Apotex Corp. | ANDA211523 |
| 62332-392-30 | 62332-392 | DAPAGLIFLOZIN DAPAGLIFLOZIN | Alembic Pharmaceuticals Inc. | ANDA211560 |
| 62332-392-91 | 62332-392 | DAPAGLIFLOZIN DAPAGLIFLOZIN | Alembic Pharmaceuticals Inc. | ANDA211560 |
| 66993-456-30 | 66993-456 | DAPAGLIFLOZIN DAPAGLIFLOZIN | Prasco Laboratories | NDA202293 |
| 67877-608-05 | 67877-608 | Dapagliflozin Dapagliflozin | Ascend Laboratories, LLC | ANDA211545 |
| 67877-608-30 | 67877-608 | Dapagliflozin Dapagliflozin | Ascend Laboratories, LLC | ANDA211545 |
| 67877-608-33 | 67877-608 | Dapagliflozin Dapagliflozin | Ascend Laboratories, LLC | ANDA211545 |
| 67877-608-90 | 67877-608 | Dapagliflozin Dapagliflozin | Ascend Laboratories, LLC | ANDA211545 |
| 69097-388-02 | 69097-388 | DAPAGLIFLOZIN DAPAGLIFLOZIN | Cipla USA Inc. | ANDA211535 |
| 70377-023-11 | 70377-023 | DAPAGLIFLOZIN DAPAGLIFLOZIN | Biocon Pharma Inc. | ANDA211470 |
| 70377-023-12 | 70377-023 | DAPAGLIFLOZIN DAPAGLIFLOZIN | Biocon Pharma Inc. | ANDA211470 |
| 70710-1380-3 | 70710-1380 | Dapagliflozin Dapagliflozin | Zydus Pharmaceuticals USA Inc. | ANDA211582 |
| 70710-1380-9 | 70710-1380 | Dapagliflozin Dapagliflozin | Zydus Pharmaceuticals USA Inc. | ANDA211582 |
| 70748-105-06 | 70748-105 | Dapagliflozin Dapagliflozin | Lupin Pharmaceuticals, Inc. | ANDA211531 |
| 70771-1714-3 | 70771-1714 | Dapagliflozin Dapagliflozin | Zydus Lifesciences Limited | ANDA211582 |
| 70771-1714-9 | 70771-1714 | Dapagliflozin Dapagliflozin | Zydus Lifesciences Limited | ANDA211582 |
| 70954-856-10 | 70954-856 | Dapagliflozin Dapagliflozin | ANI Pharmaceuticals, Inc. | ANDA211156 |
| 71921-420-09 | 71921-420 | DAPAGLIFLOZIN Dapagliflozin | Florida Pharmaceutical Products, LLC | ANDA211156 |
| 71921-420-33 | 71921-420 | DAPAGLIFLOZIN Dapagliflozin | Florida Pharmaceutical Products, LLC | ANDA211156 |
| 71921-420-50 | 71921-420 | DAPAGLIFLOZIN Dapagliflozin | Florida Pharmaceutical Products, LLC | ANDA211156 |
| 72205-432-01 | 72205-432 | Dapagliflozin Dapagliflozin | Novadoz Pharmaceuticals LLC | ANDA211478 |
| 72205-432-02 | 72205-432 | Dapagliflozin Dapagliflozin | Novadoz Pharmaceuticals LLC | ANDA211478 |
| 72205-432-03 | 72205-432 | Dapagliflozin Dapagliflozin | Novadoz Pharmaceuticals LLC | ANDA211478 |
| 73190-072-30 | 73190-072 | Dapagliflozin Dapagliflozin | AvKARE | ANDA211478 |
| 73190-072-90 | 73190-072 | Dapagliflozin Dapagliflozin | AvKARE | ANDA211478 |
Drugs@FDA Applications#
| Application | NDC | Name | Marketing category | Labeler |
|---|---|---|---|---|
| ANDA211541 | 0480-3527 | DAPAGLIFLOZIN DAPAGLIFLOZIN | ANDA | Teva Pharmaceuticals, Inc. |
| ANDA211312 | 0781-5985 | Dapagliflozin Dapagliflozin | ANDA | Sandoz Inc |
| ANDA211482 | 27241-151 | Dapagliflozin Dapagliflozin | ANDA | Ajanta Pharma USA Inc. |
| ANDA211506 | 33342-585 | dapagliflozin dapagliflozin | ANDA | Macleods Pharmaceuticals Limited |
| ANDA211560 | 46708-392 | DAPAGLIFLOZIN DAPAGLIFLOZIN | ANDA | Alembic Pharmaceuticals Limited |
| NDA202293 | 50090-7056 | DAPAGLIFLOZIN DAPAGLIFLOZIN | NDA AUTHORIZED GENERIC | A-S Medication Solutions |
| ANDA211468 | 50090-7971 | Dapagliflozin Dapagliflozin | ANDA | A-S Medication Solutions |
| ANDA211523 | 60505-4911 | Dapagliflozin DAPAGLIFLOZIN | ANDA | Apotex Corp. |
| ANDA211545 | 67877-608 | Dapagliflozin Dapagliflozin | ANDA | Ascend Laboratories, LLC |
| ANDA211535 | 69097-388 | DAPAGLIFLOZIN DAPAGLIFLOZIN | ANDA | Cipla USA Inc. |
| ANDA211470 | 70377-023 | DAPAGLIFLOZIN DAPAGLIFLOZIN | ANDA | Biocon Pharma Inc. |
| ANDA211582 | 70710-1380 | Dapagliflozin Dapagliflozin | ANDA | Zydus Pharmaceuticals USA Inc. |
| ANDA211531 | 70748-105 | Dapagliflozin Dapagliflozin | ANDA | Lupin Pharmaceuticals, Inc. |
| ANDA211156 | 70954-856 | Dapagliflozin Dapagliflozin | ANDA | ANI Pharmaceuticals, Inc. |
| ANDA211478 | 72205-432 | Dapagliflozin Dapagliflozin | ANDA | Novadoz Pharmaceuticals LLC |
UNII Substances#
No records found.
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 72ad22ae-efe6-4cd6-a302-98aaee423d69 | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 45 | These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 2014 | 20241024 |
| 40cc4f5d-bcf6-4016-9d1e-838bbc4bdddc | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 20 | These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 2014 | 20240829 |
| 01f90c94-71cb-4a1f-81ff-8004b850529b | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 15 | These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 2014 | 20231212 |
| 08baca21-e39e-4e61-961f-d89432fe8007 | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 14 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20260402 |
| 828f1004-3647-9a13-8008-c4b3759ecfd0 | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 12 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20260212 |
| 840e2146-2383-489b-bcc4-fecfe986685a | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 11 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20260407 |
| f615d81e-d1e8-4561-a4d9-286c615d3bd2 | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 10 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20250811 |
| b6b8a10c-64c3-4856-8961-d72d68784f5d | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 9 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20260320 |
| 3aba33aa-f8c6-4b10-85c8-dfa14578d07c | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 9 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20241024 |
| db668c5c-2d49-41c8-8ffd-c2b2652b621a | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 6 | Dapagliflozin Tablets | 20260406 |
| a2f86c0a-ce78-4d06-b5d8-ed457c8e3614 | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 5 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20260408 |
| 0406a1c0-56b1-4ea1-95ae-00357ac1ba7e | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 5 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20251031 |
| 82cdd5ad-df2b-4bdd-a3a6-a059040100b4 | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 4 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20240628 |
| 20a83ea2-6ad8-4bbb-b516-73c0a9e37399 | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 3 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20260428 |
| 17586ec6-0104-4b08-ad87-12a837568d6c | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 3 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20260406 |
| 52a778e7-6044-2049-e063-6294a90aa0b7 | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 2 | DAPAGLIFLOZIN tablets, for oral use These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. Initial U.S. Approval: 2014 | 20260527 |
| f56593f7-588e-489d-9fad-b459e90dab18 | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20260511 |
| bd9766c5-104f-4636-897d-b6c92eb94f18 | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20260410 |
| 107b4d25-4764-42b7-80e3-9aaff20865ed | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20260408 |
| 91373924-66dc-4277-aaf2-8536e81a0e4d | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 2 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20260407 |
| c4264ff6-5199-49e9-91d3-3ad67b42f88d | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20260518 |
| 6425d240-5dd9-4a2c-9348-f8a859702850 | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20260513 |
| ef9e9c8c-5460-4193-952a-0c249dd071bd | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use FARXIGA safely and effectively. See full prescribing information for FARXIGA. FARXIGA ® (dapagliflozin) tablets, for oral use Initial U.S. Approval: 2014 | 20260424 |
| d44f7eed-dd51-40d1-8408-8fb331e1f1f6 | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20260407 |
| 8296f538-4c23-4d6c-be53-8005b83c24b7 | dapagliflozin 5 MG Oral Tablet [PSN] · dapagliflozin 5 MG Oral Tablet [SCD] · dapagliflozin 5 MG Oral Tablet [SY] | 3 | 1 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | 20260331 |
Recently Linked DailyMed Labels#
| Set ID | Title | Manufacturer | Effective |
|---|---|---|---|
| 8296f538-4c23-4d6c-be53-8005b83c24b7 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Sandoz Inc | 20260730 |
| f56593f7-588e-489d-9fad-b459e90dab18 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20260717 |
| f56593f7-588e-489d-9fad-b459e90dab18 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20260716 |
| 91373924-66dc-4277-aaf2-8536e81a0e4d | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Macleods Pharmaceuticals Limited | 20260709 |
| 20a83ea2-6ad8-4bbb-b516-73c0a9e37399 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Florida Pharmaceutical Products, LLC | Inventia Healthcare Limited. | Inventia Healthcare Limited | 20260702 |
| 6425d240-5dd9-4a2c-9348-f8a859702850 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | ANI Pharmaceuticals, Inc. | 20260629 |
| b6b8a10c-64c3-4856-8961-d72d68784f5d | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Ascend Laboratories, LLC | Alkem Laboratories Limited | 20260625 |
| 840e2146-2383-489b-bcc4-fecfe986685a | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 20260623 |
| a2f86c0a-ce78-4d06-b5d8-ed457c8e3614 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets USP, for oral use Initial U.S. Approval: 2014 | Cipla USA Inc. | Cipla Limited | MSN Laboratories Private Limited | CIPLA LIMITED GOA | 20260622 |
| 17586ec6-0104-4b08-ad87-12a837568d6c | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20260622 |
| 107b4d25-4764-42b7-80e3-9aaff20865ed | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | MSN Pharmaceuticals Inc. | 20260617 |
| b6b8a10c-64c3-4856-8961-d72d68784f5d | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Ascend Laboratories, LLC | Alkem Laboratories Limited | 20260616 |
| 91373924-66dc-4277-aaf2-8536e81a0e4d | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Macleods Pharmaceuticals Limited | 20260608 |
| 3aba33aa-f8c6-4b10-85c8-dfa14578d07c | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Prasco Laboratories | AstraZeneca PLC | 20260603 |
| 3aba33aa-f8c6-4b10-85c8-dfa14578d07c | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Prasco Laboratories | AstraZeneca PLC | 20260603 |
| 52a778e7-6044-2049-e063-6294a90aa0b7 | DAPAGLIFLOZIN tablets, for oral use These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. Initial U.S. Approval: 2014 | AvKARE | 20260527 |
| 52a778e7-6044-2049-e063-6294a90aa0b7 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | AvKARE | 20260525 |
| c4264ff6-5199-49e9-91d3-3ad67b42f88d | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | A-S Medication Solutions | 20260518 |
| 6425d240-5dd9-4a2c-9348-f8a859702850 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | ANI Pharmaceuticals, Inc. | 20260513 |
| f56593f7-588e-489d-9fad-b459e90dab18 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20260511 |
| 20a83ea2-6ad8-4bbb-b516-73c0a9e37399 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Florida Pharmaceutical Products, LLC | Inventia Healthcare Limited. | Inventia Healthcare Limited | 20260428 |
| 840e2146-2383-489b-bcc4-fecfe986685a | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 20260422 |
| d44f7eed-dd51-40d1-8408-8fb331e1f1f6 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Alembic Pharmaceuticals Limited | 20260421 |
| bd9766c5-104f-4636-897d-b6c92eb94f18 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Apotex Corp. | Aizant Drug Research Solutions Pvt Ltd | 20260410 |
| a2f86c0a-ce78-4d06-b5d8-ed457c8e3614 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Cipla USA Inc. | Cipla Limited | MSN Laboratories Private Limited | CIPLA LIMITED GOA | 20260408 |
| 107b4d25-4764-42b7-80e3-9aaff20865ed | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | 20260408 |
| 107b4d25-4764-42b7-80e3-9aaff20865ed | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | 20260408 |
| 840e2146-2383-489b-bcc4-fecfe986685a | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 20260407 |
| 91373924-66dc-4277-aaf2-8536e81a0e4d | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Macleods Pharmaceuticals Limited | 20260407 |
| d44f7eed-dd51-40d1-8408-8fb331e1f1f6 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Alembic Pharmaceuticals Limited | 20260407 |
| f56593f7-588e-489d-9fad-b459e90dab18 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20260407 |
| db668c5c-2d49-41c8-8ffd-c2b2652b621a | Dapagliflozin Tablets | Zydus Lifesciences Limited | 20260406 |
| 17586ec6-0104-4b08-ad87-12a837568d6c | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 20260406 |
| a2f86c0a-ce78-4d06-b5d8-ed457c8e3614 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Cipla USA Inc. | Cipla Limited | MSN Laboratories Private Limited | CIPLA LIMITED GOA | 20260404 |
| 08baca21-e39e-4e61-961f-d89432fe8007 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 20260402 |
| 8296f538-4c23-4d6c-be53-8005b83c24b7 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Sandoz Inc | 20260331 |
| b6b8a10c-64c3-4856-8961-d72d68784f5d | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Ascend Laboratories, LLC | Alkem Laboratories Limited | 20260320 |
| 828f1004-3647-9a13-8008-c4b3759ecfd0 | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Biocon Pharma Inc. | Biocon Pharma Limited | Biocon Limited | Syngene International Limited | 20260212 |
| 0406a1c0-56b1-4ea1-95ae-00357ac1ba7e | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Teva Pharmaceuticals, Inc. | 20251031 |
| 0406a1c0-56b1-4ea1-95ae-00357ac1ba7e | These highlights do not include all the information needed to use DAPAGLIFLOZIN TABLETS safely and effectively. See full prescribing information for DAPAGLIFLOZIN TABLETS. DAPAGLIFLOZIN tablets, for oral use Initial U.S. Approval: 2014 | Teva Pharmaceuticals, Inc. | 20251031 |
Drug Classes#
| Source | Class ID | Class | Type | Relationship | Drug concept |
|---|---|---|---|---|---|
| ATC | A10BK | Sodium-glucose co-transporter 2 (SGLT2) inhibitors | ATC1-4 | dapagliflozin | |
| FDASPL | N0000187059 | Sodium-Glucose Cotransporter 2 Inhibitor | EPC | has_epc | dapagliflozin |
| FDASPL | N0000187058 | Sodium-Glucose Transporter 2 Inhibitors | MOA | has_moa | dapagliflozin |
| MEDRT | D001559 | Benzhydryl Compounds | CHEM | has_ingredient | dapagliflozin |
| MEDRT | D005960 | Glucosides | CHEM | has_ingredient | dapagliflozin |
| MEDRT | D003924 | Diabetes Mellitus, Type 2 | DISEASE | may_treat | dapagliflozin |
| MEDRT | D006333 | Heart Failure | DISEASE | may_treat | dapagliflozin |
| MEDRT | N0000187058 | Sodium-Glucose Transporter 2 Inhibitors | MOA | has_moa | dapagliflozin |
| MEDRT | N0000175650 | Decreased Sympathetic Activity | PE | has_pe | dapagliflozin |
| MEDRT | N0000009556 | Increased Renal Organic Ion Excretion | PE | has_pe | dapagliflozin |
| MEDRT | N0000009830 | Renal Ion Transport Alteration | PE | has_pe | dapagliflozin |
Properties#
| Category | Property | Value |
|---|---|---|
| ATTRIBUTES | AVAILABLE_STRENGTH | 5 MG |
| ATTRIBUTES | GENERAL_CARDINALITY | SINGLE |
| ATTRIBUTES | HUMAN_DRUG | US |
| ATTRIBUTES | RXNAV_HUMAN_DRUG | US |
| ATTRIBUTES | SCHEDULE | 0 |
| CODES | ANDA | ANDA211156 |
| CODES | ANDA | ANDA211312 |
| CODES | ANDA | ANDA211468 |
| CODES | ANDA | ANDA211470 |
| CODES | ANDA | ANDA211478 |
| CODES | ANDA | ANDA211482 |
| CODES | ANDA | ANDA211506 |
| CODES | ANDA | ANDA211523 |
| CODES | ANDA | ANDA211531 |
| CODES | ANDA | ANDA211535 |
| CODES | ANDA | ANDA211541 |
| CODES | ANDA | ANDA211545 |
| CODES | ANDA | ANDA211560 |
| CODES | ANDA | ANDA211582 |
| CODES | SNOMEDCT | 1145542000 |
| CODES | VUID | 4033036 |
| NAMES | Prescribable Synonym | dapagliflozin 5 MG Oral Tablet |
| SOURCES | Source | Gold Standard Alchemy |
| SOURCES | Source | Metathesaurus FDA Structured Product Labels |
| SOURCES | Source | Micromedex RED BOOK |
| SOURCES | Source | Multum MediSource Lexicon |
| SOURCES | Source | National Drug Data File Plus Source Vocabulary |
| SOURCES | Source | US Edition of SNOMED_CT |
| SOURCES | Source | Veterans Health Administration National Drug File |