Home NDC 55700-988 MOVANTIK
Product NDC 55700-988
11-digit product format 557000988
Labeler code 55700
Product ID 55700-988_170cbf79-e3d8-40d4-843c-93f55c820557
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name naloxegol oxalate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Quality Care Products, LLC
Application NDA204760
Marketing category NDA
Marketing start 2022-11-22
Marketing end 0000-00-00
Substance NALOXEGOL OXALATE
Active strength 25 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 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.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table 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 product product 55700-988 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55700-988 55700-988-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table 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# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table 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.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table 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# Patent history page 1 of 10 · 376 observed states.
Captured, Edition, Application-product table 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# DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55700-988 MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [QUALITY CARE PRODUCTS, LLC] 2 Legacy NDC 20241222_75698633-7903-4607-a08e-eae580212d7f.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.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55700-988-30 55700098830 30 TABLET, FILM COATED in 1 BOTTLE (55700-988-30) 2022-11-22 0000-00-00 No No Current