MOVANTIK

Product NDC: 0310-1970
11-digit product format: 003101970
Labeler code: 0310
Product ID: 0310-1970_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: 25 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

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.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0310-1970		D	Discontinued by firm	2026-08-03
excluded package	package	0310-1970	0310-1970-30	D	Discontinued by firm	2026-08-03
excluded package	package	0310-1970	0310-1970-39	D	Discontinued by firm	2026-08-03
excluded package	package	0310-1970	0310-1970-90	D	Discontinued by firm	2026-08-03
excluded package	package	0310-1970	0310-1970-95	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.

Historic NDC status page 1 of 1 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0310-1970-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0310-1970-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0310-1970-95	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0310-1970-39	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0310-1970-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0310-1970-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0310-1970-95	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0310-1970-39	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0310-1970-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0310-1970-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0310-1970-95	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0310-1970-39	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0310-1970-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0310-1970-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0310-1970-95	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0310-1970-39	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0310-1970-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0310-1970-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0310-1970-95	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0310-1970-39	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0310-1970-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0310-1970-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0310-1970-95	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0310-1970-39	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0310-1970-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0310-1970-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0310-1970-95	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0310-1970-39	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0310-1970-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0310-1970-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0310-1970-95	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0310-1970-39	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0310-1970-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0310-1970-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0310-1970-95	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0310-1970-39	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0310-1970-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0310-1970-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0310-1970-95	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0310-1970-39	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0310-1970-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0310-1970-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0310-1970-95	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0310-1970-39	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0310-1970-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0310-1970-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0310-1970-95	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0310-1970-39	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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	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#

Captured, Edition, Application-product table
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-1970-30	EA - Each	0310-1970	d1093d71-4ccf-4a50-a456-be3bea40a848	1	2015-03-03
0310-1970-39	EA - Each	0310-1970	20fa4579-b29f-4610-892e-76b6e9bed5f2	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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.

Brand, Generic, Manufacturer table
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	Exact identifier application applno (NDA): 204760 application number: NDA204760
MOVANTIK	NALOXEGOL OXALATE	RedHill Biopharma Ltd	300a6474-ebcd-4404-8040-48fdcfcc1635	2024-11-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204760 application number: NDA204760

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
65I14TNM33	NALOXEGOL OXALATE	1354744-91-4	NALOXEGOL OXALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0310-1970-30	00310197030	30 TABLET, FILM COATED in 1 BOTTLE (0310-1970-30)		2015-03-06	0000-00-00	No	No	Current
0310-1970-39	00310197039	10 BLISTER PACK in 1 CARTON (0310-1970-39) > 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2015-03-06	0000-00-00	No	No	Current
0310-1970-90	00310197090	90 TABLET, FILM COATED in 1 BOTTLE (0310-1970-90)		2015-03-06	0000-00-00	No	No	Current
0310-1970-95	00310197095	1 BLISTER PACK in 1 CARTON (0310-1970-95) > 3 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2015-03-06	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MOVANTIK	Quality Care Products, LLC	2020-05-21	HUMAN PRESCRIPTION DRUG LABEL	4
MOVANTIK	AstraZeneca Pharmaceuticals LP \| AstraZeneca PLC	2020-04-13	HUMAN PRESCRIPTION DRUG LABEL	17