Home NDC 0310-1969-39 MOVANTIK
Product NDC 0310-1969
Requested package NDC 0310-1969-39
11-digit product format 003101969
Labeler code 0310
Product ID 0310-1969_ffc5b181-ff54-4ad6-b6d5-793ac052041f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name naloxegol oxalate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AstraZeneca Pharmaceuticals LP
Application NDA204760
Marketing category NDA
Marketing start 2015-03-06
Marketing end 2022-12-31
Substance NALOXEGOL OXALATE
Active strength 13 mg/1
Pharmacologic classes Opioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 86 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 2026-09-14 22:38:34 2026-08 N204760-001 MOVANTIK EQ 12.5MG BASE TABLET / ORAL RLD 2014-09-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204760-002 MOVANTIK EQ 25MG BASE TABLET / ORAL RLD, RS 2014-09-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204760-001 MOVANTIK EQ 12.5MG BASE TABLET / ORAL RLD 2014-09-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204760-002 MOVANTIK EQ 25MG BASE TABLET / ORAL RLD, RS 2014-09-16 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 1 of 10 · 384 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N204760-001 7786133 2028-09-16 Drug substance, Drug product 2014-10-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204760-001 9012469 2032-04-02 Drug substance, Drug product 2015-05-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204760-002 7786133 2028-09-16 Drug substance, Drug product 2014-10-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N204760-002 9012469 2032-04-02 Drug substance, Drug product 2015-05-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N204760-001 7786133 2028-09-16 Drug substance, Drug product 2014-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204760-001 9012469 2032-04-02 Drug substance, Drug product 2015-05-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204760-002 7786133 2028-09-16 Drug substance, Drug product 2014-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204760-002 9012469 2032-04-02 Drug substance, Drug product 2015-05-15 caaa826d4ba7…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…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NALOXEGOL OXALATE ACTIVE INGREDIENT 65I14TNM33 MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 5 NALOXEGOL ACTIVE MOIETY 44T7335BKE MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 5 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 5 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 5 MANNITOL INACTIVE INGREDIENT 3OWL53L36A MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 5 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 5 PROPYL GALLATE INACTIVE INGREDIENT 8D4SNN7V92 MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 5 WATER INACTIVE INGREDIENT 059QF0KO0R MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 5
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 Units Marketing start Marketing end Sample Exclude flag Status 0310-1969-39 00310196939 10 BLISTER PACK in 1 CARTON (0310-1969-39) > 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2015-03-06 0000-00-00 No No Current