MOVANTIK
- Product NDC
- 57841-1300
- Requested package NDC
- 57841-1300-3
- 11-digit product format
- 578411300
- Labeler code
- 57841
- Product ID
- 57841-1300_046d2fd8-3056-425f-a196-7ff77450368c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naloxegol oxalate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RedHill Biopharma Ltd
- Application
- NDA204760
- Marketing category
- NDA
- Marketing start
- 2020-10-01
- Marketing end
- 0000-00-00
- Substance
- NALOXEGOL OXALATE
- Active strength
- 13 mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 57841-1300 | 57841-1300-3 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 57841-1300 | 57841-1300-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 57841-1300 | 57841-1300-3 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N204760-001 | MOVANTIK | NALOXEGOL OXALATE | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | |
| N204760-002 | MOVANTIK | NALOXEGOL OXALATE | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N204760-001 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | |
| N204760-001 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 | |
| N204760-002 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | |
| N204760-002 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 |
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 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N204760-001 | MOVANTIK | EQ 12.5MG BASE | TABLET / ORAL | RLD | 2014-09-16 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N204760-002 | MOVANTIK | EQ 25MG BASE | TABLET / ORAL | RLD, RS | 2014-09-16 | 782e0a99824c… |
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 | N204760-001 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204760-001 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204760-002 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204760-002 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204760-001 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204760-001 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204760-002 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204760-002 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204760-001 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204760-001 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204760-002 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204760-002 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204760-001 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204760-001 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204760-002 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204760-002 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204760-001 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204760-001 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204760-002 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204760-002 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204760-001 | 7056500 | 2024-06-29 | U-1185 | Drug product | 2015-06-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204760-001 | 8067431 | 2024-12-16 | U-1185 | 2014-10-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204760-001 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204760-001 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204760-002 | 7056500 | 2024-06-29 | U-1185 | Drug product | 2015-06-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204760-002 | 8067431 | 2024-12-16 | U-1185 | 2014-10-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204760-002 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204760-002 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204760-001 | 7056500 | 2024-06-29 | U-1185 | Drug product | 2015-06-05 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204760-001 | 8067431 | 2024-12-16 | U-1185 | 2014-10-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204760-001 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204760-001 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204760-002 | 7056500 | 2024-06-29 | U-1185 | Drug product | 2015-06-05 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204760-002 | 8067431 | 2024-12-16 | U-1185 | 2014-10-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204760-002 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204760-002 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204760-001 | 7056500 | 2024-06-29 | U-1185 | Drug product | 2015-06-05 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204760-001 | 8067431 | 2024-12-16 | U-1185 | 2014-10-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204760-001 | 7786133 | 2028-09-16 | Drug substance, Drug product | 2014-10-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204760-001 | 9012469 | 2032-04-02 | Drug substance, Drug product | 2015-05-15 | 5bbf6a4d5a75… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N204760-001 | NCE | 2019-09-16 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N204760-002 | NCE | 2019-09-16 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N204760-001 | NCE | 2019-09-16 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N204760-002 | NCE | 2019-09-16 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N204760-001 | NCE | 2019-09-16 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N204760-002 | NCE | 2019-09-16 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N204760-001 | NCE | 2019-09-16 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N204760-002 | NCE | 2019-09-16 | ea99ee380514… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 165eaa71-147c-4cfb-8922-5658e5aa4a66 | Product name | 1 | 20150327 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57841-1300-1 | MOVANTIK | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 5 | |
| 57841-1300-2 | MOVANTIK | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 5 | |
| 57841-1300-3 | MOVANTIK | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 5 | |
| 57841-1300-3 | MOVANTIK | 10 in 1 CARTON | TABLET, FILM COATED | 10 | 5 | |
| 57841-1300-4 | MOVANTIK | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 | |
| 57841-1300-4 | MOVANTIK | 3 in 1 BLISTER PACK | TABLET, FILM COATED | 3 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 57841-1300 | MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [REDHILL BIOPHARMA LTD] | 5 | Legacy NDC, 6 package rows | 20241129_300a6474-ebcd-4404-8040-48fdcfcc1635.zip |
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 |
|---|---|---|---|---|---|---|
| MOVANTIK | NALOXEGOL OXALATE | Valinor Pharma, LLC | 28596788-b73f-4247-85fc-3105f51fff5a | 2025-12-22 | Warnings, Adverse reactions | 204760 NDA204760 |
| MOVANTIK | NALOXEGOL OXALATE | RedHill Biopharma Ltd | 300a6474-ebcd-4404-8040-48fdcfcc1635 | 2024-11-27 | Warnings, Adverse reactions | 204760 NDA204760 57841-1300-3 57841-1300 57841130003 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1551923 | movantik 12.5 MG Oral Tablet | PSN | 300a6474-ebcd-4404-8040-48fdcfcc1635 | 5 |
| 1601373 | movantik 25 MG Oral Tablet | PSN | 300a6474-ebcd-4404-8040-48fdcfcc1635 | 5 |
| 1551917 | naloxegol 12.5 MG Oral Tablet | PSN | 300a6474-ebcd-4404-8040-48fdcfcc1635 | 5 |
| 1551782 | naloxegol 25 MG Oral Tablet | PSN | 300a6474-ebcd-4404-8040-48fdcfcc1635 | 5 |
| 1551923 | naloxegol 12.5 MG Oral Tablet [Movantik] | SBD | 300a6474-ebcd-4404-8040-48fdcfcc1635 | 5 |
| 1601373 | naloxegol 25 MG Oral Tablet [Movantik] | SBD | 300a6474-ebcd-4404-8040-48fdcfcc1635 | 5 |
| 1551917 | naloxegol 12.5 MG Oral Tablet | SCD | 300a6474-ebcd-4404-8040-48fdcfcc1635 | 5 |
| 1551782 | naloxegol 25 MG Oral Tablet | SCD | 300a6474-ebcd-4404-8040-48fdcfcc1635 | 5 |
| 1551923 | Movantik 12.5 MG (as naloxegol oxalate 14.2 MG) Oral Tablet | SY | 300a6474-ebcd-4404-8040-48fdcfcc1635 | 5 |
| 1551923 | Movantik 12.5 MG Oral Tablet | SY | 300a6474-ebcd-4404-8040-48fdcfcc1635 | 5 |
| 1601373 | Movantik 25 MG (as naloxegol oxalate 28.5 MG) Oral Tablet | SY | 300a6474-ebcd-4404-8040-48fdcfcc1635 | 5 |
| 1601373 | Movantik 25 MG Oral Tablet | SY | 300a6474-ebcd-4404-8040-48fdcfcc1635 | 5 |
| 1551917 | naloxegol 12.5 MG (as naloxegol oxalate 14.2 MG) Oral Tablet | SY | 300a6474-ebcd-4404-8040-48fdcfcc1635 | 5 |
| 1551782 | naloxegol 25 MG (as naloxegol oxalate 28.5 MG) Oral Tablet | SY | 300a6474-ebcd-4404-8040-48fdcfcc1635 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 57841-1300-3 | 57841130003 | 10 BLISTER PACK in 1 CARTON (57841-1300-3) > 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2020-10-01 | 0000-00-00 | No | No | Current |