MOVANTIK

Product NDC: 57841-1301
11-digit product format: 578411301
Labeler code: 57841
Product ID: 57841-1301_27e98e6d-9faf-3a94-e063-6394a90a1dcb
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: 2027-01-31
Substance: NALOXEGOL OXALATE
Active strength: 25 mg/1
Pharmacologic classes: Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag: No
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: MOVANTIK

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NALOXEGOL OXALATE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
65I14TNM33	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1551782	Internal RxNorm lookup
1551917	Internal RxNorm lookup
1551923	Internal RxNorm lookup
1601373	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
300a6474-ebcd-4404-8040-48fdcfcc1635	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
Package NDC	Product	Description	Form	Quantity	SPL version
57841-1301-1	MOVANTIK	30 in 1 BOTTLE	TABLET, FILM COATED	30	5
57841-1301-2	MOVANTIK	90 in 1 BOTTLE	TABLET, FILM COATED	90	5
57841-1301-3	MOVANTIK	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	5
57841-1301-3	MOVANTIK	10 in 1 CARTON	TABLET, FILM COATED	10	5
57841-1301-4	MOVANTIK	1 in 1 CARTON	TABLET, FILM COATED	1	5
57841-1301-4	MOVANTIK	3 in 1 BLISTER PACK	TABLET, FILM COATED	3	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57841-1301	MOVANTIK (NALOXEGOL OXALATE) TABLET, FILM COATED [REDHILL BIOPHARMA LTD]	5	Current NDC, 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.

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 ndc (product): 57841-1301

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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 table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57841-1301-1	57841130101	30 TABLET, FILM COATED in 1 BOTTLE (57841-1301-1)		2020-10-01	2027-01-31	No	No	Current
57841-1301-2	57841130102	90 TABLET, FILM COATED in 1 BOTTLE (57841-1301-2)		2020-10-01	2027-01-31	No	No	Current
57841-1301-3	57841130103	10 BLISTER PACK in 1 CARTON (57841-1301-3) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2020-10-01	2027-01-31	No	No	Current
57841-1301-4	57841130104	1 BLISTER PACK in 1 CARTON (57841-1301-4) / 3 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2020-10-01	2027-01-31	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MOVANTIK	Quality Care Products, LLC	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	2
MOVANTIK	RedHill Biopharma Ltd	2024-11-27	HUMAN PRESCRIPTION DRUG LABEL	5