ranolazine
- Product NDC
- 69844-025
- 11-digit product format
- 698440025
- Labeler code
- 69844
- Product ID
- 69844-025_ef140e7b-b519-b66d-e053-2a95a90a2305
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- extended-release
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Graviti Pharmaceuticals Private Limited
- Application
- ANDA212889
- Marketing category
- ANDA
- Marketing start
- 2021-01-28
- Marketing end
- 0000-00-00
- Substance
- RANOLAZINE
- Active strength
- 1000 mg/1
- Pharmacologic classes
- Anti-anginal [EPC], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212889-001 | RANOLAZINE | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | |
| A212889-002 | RANOLAZINE | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212889-001 | AB |
| A212889-002 | AB |
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 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212889-001 | RANOLAZINE | 500MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212889-002 | RANOLAZINE | 1GM | TABLET, EXTENDED RELEASE / ORAL | AB | 2021-01-28 | 87673890dc5c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A212889-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212889-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212889-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212889-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212889-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212889-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212889-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212889-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212889-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212889-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212889-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212889-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212889-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212889-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212889-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212889-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212889-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212889-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A212889-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212889-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212889-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212889-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212889-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212889-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212889-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212889-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A212889-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A212889-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212889-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A212889-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A212889-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A212889-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A212889-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A212889-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A212889-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A212889-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A212889-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A212889-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212889-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A212889-002 | AB | 1 | 87673890dc5c… |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69844-025-01 | 69844002501 | 30 TABLET in 1 BOTTLE (69844-025-01) | 30 tablet | 2021-01-28 | 0000-00-00 | No | No | Current |
| 69844-025-02 | 69844002502 | 60 TABLET in 1 BOTTLE (69844-025-02) | 60 tablet | 2021-01-28 | 0000-00-00 | No | No | Current |
| 69844-025-03 | 69844002503 | 500 TABLET in 1 BOTTLE (69844-025-03) | 500 tablet | 2021-01-28 | 0000-00-00 | No | No | Current |