ONDANSETRON
- Product NDC
- 63187-065
- 11-digit product format
- 631870065
- Labeler code
- 63187
- Product ID
- 63187-065_dcd5d6d3-2419-467f-91c2-50586e9ca5cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ONDANSETRON
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077851
- Marketing category
- ANDA
- Marketing start
- 2007-06-25
- Substance
- ONDANSETRON HYDROCHLORIDE
- Active strength
- 8 mg/1
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077851-001 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | |
| A077851-002 | ONDANSETRON HYDROCHLORIDE | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077851-001 | AB |
| A077851-002 | 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 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077851-001 | ONDANSETRON HYDROCHLORIDE | EQ 4MG BASE | TABLET / ORAL | AB | 2007-06-25 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077851-002 | ONDANSETRON HYDROCHLORIDE | EQ 8MG BASE | TABLET / ORAL | AB | 2007-06-25 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077851-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077851-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077851-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077851-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077851-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077851-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077851-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077851-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077851-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077851-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077851-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077851-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077851-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077851-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077851-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077851-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077851-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077851-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077851-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077851-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077851-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077851-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077851-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077851-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077851-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077851-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077851-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077851-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077851-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077851-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077851-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077851-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077851-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077851-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077851-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077851-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077851-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077851-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077851-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A077851-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ONDANSETRON
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ONDANSETRON HYDROCHLORIDE | 8 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| NMH84OZK2B | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 41c0dc3d-a616-425e-9073-625a0cb692c4 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d9bd4853-037c-6968-f4d4-9bb9a0efd1ea | Product name | 2 | 20250722 |
| 32e23bc9-ce14-4555-bb6d-bcb654d7d296 | Product name | 1 | 20201015 |
| e459f50a-1553-4aab-b6bd-1e5f0c211c49 | Product name | 1 | 20201015 |
| 909480fe-0d18-c1c1-a658-0bd9a7131822 | Product name | 5 | 20170829 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63187-065-10 | ONDANSETRON | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | 4 | |
| 63187-065-15 | ONDANSETRON | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | 4 | |
| 63187-065-20 | ONDANSETRON | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 4 | |
| 63187-065-30 | ONDANSETRON | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 4 | |
| 63187-065-60 | ONDANSETRON | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 4 | |
| 63187-065-90 | ONDANSETRON | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63187-065-30 | EA - Each | 63187-065 | e87d79f9-6687-4093-9617-345aa7c6e2e8 | 1 | 2016-04-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ondansetron | ONDANSETRON HYDROCHLORIDE | Ascend Laboratories, LLC | 2edc0788-dc38-4d21-ba8e-71f159e2d3b1 | 2026-07-22 | Warnings, Adverse reactions | 077851 ANDA077851 |
| Ondansetron | ONDANSETRON | REMEDYREPACK INC. | 36592150-7e19-474c-9f96-cc8341e28b5d | 2026-03-20 | Warnings, Adverse reactions | 077851 ANDA077851 |
| Ondansetron | ONDANSETRON | Golden State Medical Supply, Inc. | 2b9ea1fc-59a4-8189-e063-6394a90a9ae6 | 2026-01-27 | Warnings, Adverse reactions | 077851 ANDA077851 |
| Ondansetron | ONDANSETRON | Natco Pharma USA LLC | 64527de5-0b92-4340-9243-7a37e8ff96d9 | 2025-12-19 | Warnings, Adverse reactions | 077851 ANDA077851 |
| Ondansetron | ONDANSETRON | Bryant Ranch Prepack | f08f56de-8678-4da9-8cae-013a5c393453 | 2024-10-02 | Warnings, Adverse reactions | 077851 ANDA077851 |
| Ondansetron | ONDANSETRON TABLETS | Natco Pharma Limited | 59c817b7-a1c6-48a5-9bfc-2c381532bfd9 | 2021-11-29 | Warnings, Adverse reactions | 077851 ANDA077851 |
| ondansetron | ONDANSETRON HYDROCHLORIDE | Proficient Rx LP | bde7c22c-0047-4735-8df6-b48e8dfa478a | 2021-01-01 | Warnings, Adverse reactions | 077851 ANDA077851 |
| ONDANSETRON | ONDANSETRON | Proficient Rx LP | 41c0dc3d-a616-425e-9073-625a0cb692c4 | 2019-11-01 | Warnings, Adverse reactions | 077851 ANDA077851 63187-065 |
| ONDANSETRON | ONDANSETRON | Sun Pharmaceutical Industries, Inc. | 834bc56a-657d-4733-9a60-47040cb5c7bf | 2019-09-11 | Warnings, Adverse reactions | 077851 ANDA077851 |
| ondansetron | ONDANSETRON HYDROCHLORIDE | Bryant Ranch Prepack | 37de0550-a6d1-46a8-a0b8-447b0dcf70ad | 2019-06-12 | Warnings, Adverse reactions | 077851 ANDA077851 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198052 | ondansetron HCl 4 MG Oral Tablet | PSN | 41c0dc3d-a616-425e-9073-625a0cb692c4 | 4 |
| 312086 | ondansetron HCl 8 MG Oral Tablet | PSN | 41c0dc3d-a616-425e-9073-625a0cb692c4 | 4 |
| 198052 | ondansetron 4 MG Oral Tablet | SCD | 41c0dc3d-a616-425e-9073-625a0cb692c4 | 4 |
| 312086 | ondansetron 8 MG Oral Tablet | SCD | 41c0dc3d-a616-425e-9073-625a0cb692c4 | 4 |
| 198052 | ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral Tablet | SY | 41c0dc3d-a616-425e-9073-625a0cb692c4 | 4 |
| 312086 | ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral Tablet | SY | 41c0dc3d-a616-425e-9073-625a0cb692c4 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63187-065-10 | 63187006510 | 10 TABLET, FILM COATED in 1 BOTTLE (63187-065-10) | 2014-04-01 | 0000-00-00 | No | No | Current |
| 63187-065-15 | 63187006515 | 15 TABLET, FILM COATED in 1 BOTTLE (63187-065-15) | 2014-04-01 | 0000-00-00 | No | No | Current |
| 63187-065-20 | 63187006520 | 20 TABLET, FILM COATED in 1 BOTTLE (63187-065-20) | 2014-04-01 | 0000-00-00 | No | No | Current |
| 63187-065-30 | 63187006530 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-065-30) | 2014-04-01 | 0000-00-00 | No | No | Current |
| 63187-065-60 | 63187006560 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-065-60) | 2014-04-01 | 0000-00-00 | No | No | Current |
| 63187-065-90 | 63187006590 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-065-90) | 2014-04-01 | 0000-00-00 | No | No | Current |