TOPROL

Product NDC: 70347-025
11-digit product format: 703470025
Labeler code: 70347
Product ID: 70347-025_281e1868-3ef6-49a4-b228-97289bf39aaa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoprolol succinate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Aralez Pharmaceuticals US Inc.
Application: NDA019962
Marketing category: NDA
Marketing start: 2018-01-01
Marketing end: 0000-00-00
Substance: METOPROLOL SUCCINATE
Active strength: 25 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
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.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70347-025		I	Inactivated by FDA	2026-08-10
excluded package	package	70347-025	70347-025-02	I	Inactivated by FDA	2026-08-10
excluded package	package	70347-025	70347-025-03	I	Inactivated by FDA	2026-08-10

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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70347-025-02	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70347-025-03	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70347-025-02	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70347-025-03	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70347-025-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70347-025-03	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70347-025-02	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70347-025-03	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70347-025-02	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70347-025-03	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70347-025-02	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70347-025-03	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70347-025-02	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70347-025-03	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70347-025-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70347-025-03	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70347-025-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70347-025-03	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019962-001	TOPROL-XL	METOPROLOL SUCCINATE	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10
N019962-002	TOPROL-XL	METOPROLOL SUCCINATE	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10
N019962-003	TOPROL-XL	METOPROLOL SUCCINATE	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10
N019962-004	TOPROL-XL	METOPROLOL SUCCINATE	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N019962-001	AB
N019962-002	AB
N019962-003	AB
N019962-004	AB

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 5 · 164 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	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019962-001	TOPROL-XL	EQ 50MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019962-002	TOPROL-XL	EQ 100MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1992-01-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019962-003	TOPROL-XL	EQ 200MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1992-01-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019962-004	TOPROL-XL	EQ 25MG TARTRATE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2001-02-05	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019962-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019962-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019962-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019962-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019962-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019962-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019962-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019962-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019962-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019962-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019962-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019962-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019962-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019962-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019962-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019962-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019962-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019962-004	AB	1	`d06236e962d9…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fac0d979-ed64-4395-be9a-fc0b6f8c0a4f	Product name	1	20260122
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
07ea0487-5434-6896-2497-013a7ee4afbd	Product name	9	20250311
95ced987-af5e-4bea-8119-4e7d4558d21b	Product name	2	20200617
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
9ab5a42a-e77d-486b-bb1f-b343fe664ada	Product name	1	20180430
310125de-e7c0-730d-d178-98b990a0334a	Product name	2	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70347-025-02	2025-01-30	These highlights do not include all the information needed to use TOPROL-XL ® safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL ® (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992
70347-025-03	2025-01-30	These highlights do not include all the information needed to use TOPROL-XL ® safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL ® (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992
70347-025-01	2021-02-10	These highlights do not include all the information needed to use TOPROL-XL ® safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL ® (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992
70347-025-02	2021-02-10	These highlights do not include all the information needed to use TOPROL-XL ® safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL ® (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992
70347-025-03	2021-02-10	These highlights do not include all the information needed to use TOPROL-XL ® safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL ® (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992
70347-025-01	2021-01-29	These highlights do not include all the information needed to use TOPROL-XL ® safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL ® (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992
70347-025-02	2021-01-29	These highlights do not include all the information needed to use TOPROL-XL ® safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL ® (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992
70347-025-03	2021-01-29	These highlights do not include all the information needed to use TOPROL-XL ® safely and effectively. See full prescribing information for TOPROL-XL. TOPROL-XL ® (metoprolol succinate) Tablet, Extended-Release for Oral Use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70347-025-02	TOPROLXL	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		20
70347-025-03	TOPROLXL	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70347-025-02	EA - Each	70347-025	da29b4e9-c091-49cd-b73c-ce70dbe4a54f	1	2018-01-12
70347-025-03	EA - Each	70347-025	c79d2c2c-c189-4a5b-9633-c1dfb6e6677d	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70347-025	TOPROL XL (METOPROLOL SUCCINATE) TABLET, EXTENDED RELEASE [ARALEZ PHARMACEUTICALS US INC.]	20	Legacy NDC, 2 package rows	20230425_991fe00b-498b-400e-9e5b-921cb07d9b2c.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOPROL XL	METOPROLOL SUCCINATE	Melinta Therapeutics, LLC	496ddfaa-7c9c-4888-b747-a210249b367a	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019962 application number: NDA019962
METOPROLOL SUCCINATE	METOPROLOL SUCCINATE	Proficient Rx LP	e236f1ed-b400-4854-81c7-64964422a2f7	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019962 application number: NDA019962
TOPROL XL	METOPROLOL SUCCINATE	Aphena Pharma Solutions - Tennessee, LLC	a07891a5-152e-4a38-8179-e05a90458a7d	2018-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 019962 application number: NDA019962

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TH25PD4CCB	METOPROLOL SUCCINATE	98418-47-4	METOPROLOL SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866412	metoprolol succinate 100 MG 24HR Extended Release Oral Tablet	PSN	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866419	metoprolol succinate 200 MG 24HR Extended Release Oral Tablet	PSN	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866427	metoprolol succinate 25 MG 24HR Extended Release Oral Tablet	PSN	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866436	metoprolol succinate 50 MG 24HR Extended Release Oral Tablet	PSN	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866414	Toprol XL 100 MG 24HR Extended Release Oral Tablet	PSN	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866421	Toprol XL 200 MG 24HR Extended Release Oral Tablet	PSN	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866429	Toprol XL 25 MG 24HR Extended Release Oral Tablet	PSN	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866438	Toprol XL 50 MG 24HR Extended Release Oral Tablet	PSN	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866414	24 HR metoprolol succinate 100 MG Extended Release Oral Tablet [Toprol]	SBD	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866421	24 HR metoprolol succinate 200 MG Extended Release Oral Tablet [Toprol]	SBD	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866429	24 HR metoprolol succinate 25 MG Extended Release Oral Tablet [Toprol]	SBD	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866438	24 HR metoprolol succinate 50 MG Extended Release Oral Tablet [Toprol]	SBD	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866412	24 HR metoprolol succinate 100 MG Extended Release Oral Tablet	SCD	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866419	24 HR metoprolol succinate 200 MG Extended Release Oral Tablet	SCD	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866427	24 HR metoprolol succinate 25 MG Extended Release Oral Tablet	SCD	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866436	24 HR metoprolol succinate 50 MG Extended Release Oral Tablet	SCD	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866412	24 HR metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate) Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866419	24 HR metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate) Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866427	24 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866436	24 HR metoprolol succinate 50 MG (as metoprolol succinate 47.5 MG equivalent to 50 MG metoprolol tartrate) Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866414	24 HR Toprol 100 MG Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866421	24 HR Toprol 200 MG Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866429	24 HR Toprol 25 MG Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866438	24 HR Toprol 50 MG Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866414	24 HR Toprol XL 100 MG Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866421	24 HR Toprol XL 200 MG Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866429	24 HR Toprol XL 25 MG Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866412	metoprolol succinate 100 MG 24 HR Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866419	metoprolol succinate 200 MG 24 HR Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866427	metoprolol succinate 25 MG 24 HR Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866436	metoprolol succinate 50 MG 24 HR Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866414	Toprol XL (metoprolol succinate 100 MG (as metoprolol succinate 95 MG equivalent to 100 MG metoprolol tartrate)) 24 HR Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866421	Toprol XL (metoprolol succinate 200 MG (as metoprolol succinate 190 MG equivalent to 200 MG metoprolol tartrate)) 24 HR Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866429	Toprol XL (metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate)) 24 HR Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866438	Toprol XL (metoprolol succinate 50 MG (as metoprolol succinate 49.5 MG equivalent to 500 MG metoprolol tartrate)) 24 HR Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866414	Toprol XL 100 MG 24 HR Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866421	Toprol XL 200 MG 24 HR Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866429	Toprol XL 25 MG 24 HR Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866438	Toprol XL 50 MG 24 HR Extended Release Oral Tablet	SY	991fe00b-498b-400e-9e5b-921cb07d9b2c	20
866427	metoprolol succinate 25 MG 24HR Extended Release Oral Tablet	PSN	a07891a5-152e-4a38-8179-e05a90458a7d	1
866429	Toprol XL 25 MG 24HR Extended Release Oral Tablet	PSN	a07891a5-152e-4a38-8179-e05a90458a7d	1
866429	24 HR metoprolol succinate 25 MG Extended Release Oral Tablet [Toprol]	SBD	a07891a5-152e-4a38-8179-e05a90458a7d	1
866427	24 HR metoprolol succinate 25 MG Extended Release Oral Tablet	SCD	a07891a5-152e-4a38-8179-e05a90458a7d	1
866427	24 HR metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate) Extended Release Oral Tablet	SY	a07891a5-152e-4a38-8179-e05a90458a7d	1
866429	24 HR Toprol 25 MG Extended Release Oral Tablet	SY	a07891a5-152e-4a38-8179-e05a90458a7d	1
866429	24 HR Toprol XL 25 MG Extended Release Oral Tablet	SY	a07891a5-152e-4a38-8179-e05a90458a7d	1
866427	metoprolol succinate 25 MG 24 HR Extended Release Oral Tablet	SY	a07891a5-152e-4a38-8179-e05a90458a7d	1
866429	Toprol XL (metoprolol succinate 25 MG (as metoprolol succinate 23.75 MG equivalent to 25 MG metoprolol tartrate)) 24 HR Extended Release Oral Tablet	SY	a07891a5-152e-4a38-8179-e05a90458a7d	1
866429	Toprol XL 25 MG 24 HR Extended Release Oral Tablet	SY	a07891a5-152e-4a38-8179-e05a90458a7d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70347-025-01	70347002501	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70347-025-01)	2018-01-01	0000-00-00	No	No	Current
70347-025-02	70347002502	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70347-025-02)	2018-01-01	0000-00-00	No	No	Current
70347-025-03	70347002503	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70347-025-03)	2018-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TOPROL XL	Aralez Pharmaceuticals US Inc. \| AstraZeneca AB	2023-04-24	HUMAN PRESCRIPTION DRUG LABEL	20
TOPROL XL	REMEDYREPACK INC.	2019-08-12	HUMAN PRESCRIPTION DRUG LABEL	3
TOPROL XL	Aphena Pharma Solutions - Tennessee, LLC	2018-02-20	HUMAN PRESCRIPTION DRUG LABEL	1