Jardiance
- Product NDC
- 70518-2447
- Requested package NDC
- 70518-2447-0
- 11-digit product format
- 705182447
- Labeler code
- 70518
- Product ID
- 70518-2447_dbd9af19-74f7-c3ec-e053-2a95a90ae411
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Empagliflozin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA204629
- Marketing category
- NDA
- Marketing start
- 2019-11-22
- Marketing end
- 0000-00-00
- Substance
- EMPAGLIFLOZIN
- Active strength
- 25 mg/1
- Pharmacologic classes
- Sodium-Glucose Cotransporter 2 Inhibitor [EPC], Sodium-Glucose Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 70518-2447 | 70518-2447-0 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-2447 | 70518-2447-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-2447 | 70518-2447-0 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N204629-001 | JARDIANCE | EMPAGLIFLOZIN | 10MG | TABLET / ORAL | RLD | 2014-08-01 | |
| N204629-002 | JARDIANCE | EMPAGLIFLOZIN | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N204629-001 | 7713938 | 2027-04-15 | Drug substance, Drug product | 2014-08-15 | |
| N204629-001 | 7713938*PED | 2027-10-15 | Pediatric extension | ||
| N204629-001 | 7579449 | 2028-08-01 | Drug substance | 2014-08-15 | |
| N204629-001 | 7579449*PED | 2029-02-01 | Pediatric extension | ||
| N204629-001 | 8551957 | 2029-10-14 | U-1651 | 2016-03-14 | |
| N204629-001 | 12115179 | 2030-02-11 | U-4023 | 2024-11-12 | |
| N204629-001 | 8551957*PED | 2030-04-14 | Pediatric extension | ||
| N204629-001 | 12115179*PED | 2030-08-11 | Pediatric extension | ||
| N204629-001 | 12527810 | 2033-04-22 | U-4403 | 2026-02-10 | |
| N204629-001 | 12527810*PED | 2033-10-22 | Pediatric extension | ||
| N204629-001 | 10258637 | 2034-04-03 | U-2290 | 2019-04-30 | |
| N204629-001 | 11090323 | 2034-04-03 | U-3191 | 2021-08-20 | |
| N204629-001 | 11666590 | 2034-04-03 | U-3691 | 2023-10-03 | |
| N204629-001 | 11813275 | 2034-04-03 | U-3759 | 2023-12-13 | |
| N204629-001 | 11813275 | 2034-04-03 | U-3760 | 2023-12-13 | |
| N204629-001 | 11833166 | 2034-04-03 | U-3776 | 2024-01-03 | |
| N204629-001 | 11833166 | 2034-04-03 | U-3777 | 2024-01-03 | |
| N204629-001 | 12263153 | 2034-04-03 | U-4171 | 2025-04-29 | |
| N204629-001 | 12427162 | 2034-04-03 | U-4287 | 2025-10-17 | |
| N204629-001 | 12433906 | 2034-04-03 | U-4293 | 2025-10-30 | |
| N204629-001 | 12433906 | 2034-04-03 | U-4294 | 2025-10-30 | |
| N204629-001 | 12433906 | 2034-04-03 | U-4295 | 2025-10-30 | |
| N204629-001 | 12433906 | 2034-04-03 | U-4296 | 2025-10-30 | |
| N204629-001 | 12433906 | 2034-04-03 | U-4304 | 2025-10-30 | |
| N204629-001 | 9949997 | 2034-05-17 | U-2292 | 2018-05-15 | |
| N204629-001 | 9949997 | 2034-05-17 | U-3199 | 2018-05-15 | |
| N204629-001 | 9949997 | 2034-05-17 | U-3325 | 2018-05-15 | |
| N204629-001 | 9949998 | 2034-06-11 | U-2290 | 2018-05-15 | |
| N204629-001 | 10258637*PED | 2034-10-03 | Pediatric extension | ||
| N204629-001 | 11090323*PED | 2034-10-03 | Pediatric extension | ||
| N204629-001 | 11813275*PED | 2034-10-03 | Pediatric extension | ||
| N204629-001 | 11833166*PED | 2034-10-03 | Pediatric extension | ||
| N204629-001 | 12433906*PED | 2034-10-03 | Pediatric extension | ||
| N204629-001 | 9949997*PED | 2034-11-17 | Pediatric extension | ||
| N204629-001 | 9949998*PED | 2034-12-11 | Pediatric extension | ||
| N204629-002 | 7713938 | 2027-04-15 | Drug substance, Drug product | 2014-08-15 | |
| N204629-002 | 7713938*PED | 2027-10-15 | Pediatric extension | ||
| N204629-002 | 7579449 | 2028-08-01 | Drug substance | 2014-08-15 | |
| N204629-002 | 7579449*PED | 2029-02-01 | Pediatric extension | ||
| N204629-002 | 8551957 | 2029-10-14 | U-1651 | 2016-03-14 | |
| N204629-002 | 12115179 | 2030-02-11 | U-4023 | 2024-11-12 | |
| N204629-002 | 8551957*PED | 2030-04-14 | Pediatric extension | ||
| N204629-002 | 12115179*PED | 2030-08-11 | Pediatric extension | ||
| N204629-002 | 12527810 | 2033-04-22 | U-4403 | 2026-02-10 | |
| N204629-002 | 12527810*PED | 2033-10-22 | Pediatric extension | ||
| N204629-002 | 10258637 | 2034-04-03 | U-2290 | 2019-04-30 | |
| N204629-002 | 11090323 | 2034-04-03 | U-3191 | 2021-08-20 | |
| N204629-002 | 11833166 | 2034-04-03 | U-3776 | 2024-01-03 | |
| N204629-002 | 11833166 | 2034-04-03 | U-3777 | 2024-01-03 | |
| N204629-002 | 12263153 | 2034-04-03 | U-4171 | 2025-04-29 | |
| N204629-002 | 12427162 | 2034-04-03 | U-4287 | 2025-10-17 | |
| N204629-002 | 12433906 | 2034-04-03 | U-4293 | 2025-10-30 | |
| N204629-002 | 12433906 | 2034-04-03 | U-4294 | 2025-10-30 | |
| N204629-002 | 12433906 | 2034-04-03 | U-4295 | 2025-10-30 | |
| N204629-002 | 12433906 | 2034-04-03 | U-4296 | 2025-10-30 | |
| N204629-002 | 12433906 | 2034-04-03 | U-4304 | 2025-10-30 | |
| N204629-002 | 9949997 | 2034-05-17 | U-2292 | 2018-05-15 | |
| N204629-002 | 9949998 | 2034-06-11 | U-2290 | 2018-05-15 | |
| N204629-002 | 10258637*PED | 2034-10-03 | Pediatric extension | ||
| N204629-002 | 11090323*PED | 2034-10-03 | Pediatric extension | ||
| N204629-002 | 11833166*PED | 2034-10-03 | Pediatric extension | ||
| N204629-002 | 12433906*PED | 2034-10-03 | Pediatric extension | ||
| N204629-002 | 9949997*PED | 2034-11-17 | Pediatric extension | ||
| N204629-002 | 9949998*PED | 2034-12-11 | Pediatric extension |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N204629-001 | NPP | 2026-06-20 |
| N204629-001 | I-922 | 2026-09-21 |
| N204629-001 | PED | 2026-12-20 |
| N204629-002 | NPP | 2026-06-20 |
| N204629-002 | PED | 2026-12-20 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N204629-001 | JARDIANCE | 10MG | TABLET / ORAL | RLD | 2014-08-01 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N204629-002 | JARDIANCE | 25MG | TABLET / ORAL | RLD, RS | 2014-08-01 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-01-26 05:58 UTC | 2023-01 | N204629-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N204629-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N204629-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N204629-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N204629-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N204629-002 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N204629-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N204629-002 | AB | 1 | e64feba35796… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 7713938 | 2027-04-15 | Drug substance, Drug product | 2014-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 7713938*PED | 2027-10-15 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 7579449 | 2028-08-01 | Drug substance | 2014-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 7579449*PED | 2029-02-01 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 8551957 | 2029-10-14 | U-1651 | 2016-03-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 12115179 | 2030-02-11 | U-4023 | 2024-11-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 8551957*PED | 2030-04-14 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 12115179*PED | 2030-08-11 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 12527810 | 2033-04-22 | U-4403 | 2026-02-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 10258637 | 2034-04-03 | U-2290 | 2019-04-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 11090323 | 2034-04-03 | U-3191 | 2021-08-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 11666590 | 2034-04-03 | U-3691 | 2023-10-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 11813275 | 2034-04-03 | U-3759 | 2023-12-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 11813275 | 2034-04-03 | U-3760 | 2023-12-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 11833166 | 2034-04-03 | U-3776 | 2024-01-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 11833166 | 2034-04-03 | U-3777 | 2024-01-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 12263153 | 2034-04-03 | U-4171 | 2025-04-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 12427162 | 2034-04-03 | U-4287 | 2025-10-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 12433906 | 2034-04-03 | U-4304 | 2025-10-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 12433906 | 2034-04-03 | U-4293 | 2025-10-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 12433906 | 2034-04-03 | U-4294 | 2025-10-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 12433906 | 2034-04-03 | U-4295 | 2025-10-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 12433906 | 2034-04-03 | U-4296 | 2025-10-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 9949997 | 2034-05-17 | U-2292 | 2018-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 9949997 | 2034-05-17 | U-3325 | 2018-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 9949997 | 2034-05-17 | U-3199 | 2018-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 9949998 | 2034-06-11 | U-2290 | 2018-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 10258637*PED | 2034-10-03 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 11090323*PED | 2034-10-03 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 11813275*PED | 2034-10-03 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 11833166*PED | 2034-10-03 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 12433906*PED | 2034-10-03 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 9949997*PED | 2034-11-17 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | 9949998*PED | 2034-12-11 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204629-002 | 7713938 | 2027-04-15 | Drug substance, Drug product | 2014-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-002 | 7713938*PED | 2027-10-15 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204629-002 | 7579449 | 2028-08-01 | Drug substance | 2014-08-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-002 | 7579449*PED | 2029-02-01 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N204629-002 | 8551957 | 2029-10-14 | U-1651 | 2016-03-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-002 | 12115179 | 2030-02-11 | U-4023 | 2024-11-12 | 011fe1cb6892… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | NPP | 2026-06-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | I-922 | 2026-09-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-001 | PED | 2026-12-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-002 | NPP | 2026-06-20 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204629-002 | PED | 2026-12-20 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204629-001 | M-82 | 2025-02-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204629-001 | PED | 2025-08-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204629-001 | NPP | 2026-06-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204629-001 | I-922 | 2026-09-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204629-001 | PED | 2026-12-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204629-002 | NPP | 2026-06-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204629-002 | PED | 2026-12-20 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N204629-001 | M-82 | 2025-02-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204629-001 | PED | 2025-08-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204629-001 | NPP | 2026-06-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204629-001 | I-922 | 2026-09-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204629-001 | PED | 2026-12-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204629-002 | NPP | 2026-06-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204629-002 | PED | 2026-12-20 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204629-001 | M-82 | 2025-02-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204629-001 | PED | 2025-08-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204629-001 | NPP | 2026-06-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204629-001 | I-922 | 2026-09-21 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204629-001 | PED | 2026-12-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204629-002 | NPP | 2026-06-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204629-002 | PED | 2026-12-20 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204629-001 | M-82 | 2025-02-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204629-001 | PED | 2025-08-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204629-001 | NPP | 2026-06-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204629-001 | I-922 | 2026-09-21 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204629-001 | PED | 2026-12-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204629-002 | NPP | 2026-06-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204629-002 | PED | 2026-12-20 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204629-001 | I-869 | 2024-08-18 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204629-001 | M-82 | 2025-02-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204629-001 | PED | 2025-08-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204629-001 | NPP | 2026-06-20 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204629-001 | I-922 | 2026-09-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204629-001 | PED | 2026-12-20 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204629-002 | NPP | 2026-06-20 | 03ed91905a0d… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Jardiance | EMPAGLIFLOZIN | Aphena Pharma Solutions - Tennessee, LLC | 334f1b3d-5670-6685-e063-6294a90a7e47 | 2026-06-17 | Warnings, Adverse reactions | 204629 NDA204629 |
| Jardiance | EMPAGLIFLOZIN | Cardinal Health 107, LLC | 5777b8a8-ada6-4950-8548-43a1de11f075 | 2026-02-17 | Warnings, Adverse reactions | 204629 NDA204629 |
| Jardiance | EMPAGLIFLOZIN | Boehringer Ingelheim Pharmaceuticals, Inc. | faf3dd6a-9cd0-39c2-0d2e-232cb3f67565 | 2026-01-30 | Warnings, Adverse reactions | 204629 NDA204629 |
| Jardiance | EMPAGLIFLOZIN | Aphena Pharma Solutions - Tennessee, LLC | 8b6261f6-4bdc-462e-8af1-4064664c62f3 | 2025-10-27 | Warnings, Adverse reactions | 204629 NDA204629 |
| Jardiance | EMPAGLIFLOZIN | A-S Medication Solutions | a77214ca-572e-485e-aae9-f7950187e5fb | 2023-08-08 | Warnings, Adverse reactions | 204629 NDA204629 |
| JARDIANCE | EMPAGLIFLOZIN | A-S Medication Solutions | 942a82a4-cbbd-4e44-9965-8d03f767912b | 2023-07-24 | Warnings, Adverse reactions | 204629 NDA204629 |
| JARDIANCE | EMPAGLIFLOZIN | A-S Medication Solutions | 1782b947-4a72-4feb-a488-1469d9af82bd | 2023-05-03 | Warnings, Adverse reactions | 204629 NDA204629 |
| JARDIANCE | EMPAGLIFLOZIN | A-S Medication Solutions | f2b41c77-0abb-40ee-8578-86a748d0e19e | 2023-05-03 | Warnings, Adverse reactions | 204629 NDA204629 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-2447-0 | 70518244700 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2447-0) | 2019-11-22 | 0000-00-00 | No | No | Current |