Application 074141

Type: ANDA
Sponsor: HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	50MG	No	No
002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	TABLET;ORAL	100MG	No	No

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
A074141-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET / ORAL			1995-01-31
A074141-002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET / ORAL			1995-01-31

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL		1995-01-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL		1995-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074141-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1995-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074141-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1995-01-31	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A074141-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074141-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A074141-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A074141-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074141-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A074141-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074141-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A074141-002	AB	1	`ea99ee380514…`

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 4 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoprolol	METOPROLOL TARTRATE	Fresenius Kabi USA, LLC	ccb1a15e-c943-4042-ae46-550bdabfc96b	2026-02-02	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Direct_Rx	499ce022-12a7-e4e5-e063-6394a90a435a	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Advagen Pharma Limited	d62a972a-bc45-4582-9701-bed27a1a9e4d	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
LOPRESSOR	METOPROLOL TARTRATE	VALIDUS PHARMACEUTICALS LLC	b5f4fed2-369c-4808-a682-8a5b8cfdbb4f	2026-01-26	Warnings, Adverse reactions	Name fallback generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	18f44ba2-d431-4a73-ac78-83e734fde694	2026-01-16	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Advagen Pharma Limited	a401fe31-d51a-49d9-a062-c9d22088db56	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	d3628f24-8076-4980-a358-8445ef8260f4	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Direct_Rx	3bb62867-cf85-ce6d-e063-6294a90ad17f	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	19678edf-934a-45f3-b5da-94d10e9b3248	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL	NuCare Pharmaceuticals, Inc.	47d11c0c-82dd-33b1-e063-6394a90a6a97	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	NuCare Pharmaceuticals, Inc.	47d18ba7-558d-1190-e063-6294a90a958f	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Northwind Health Company, LLC	e07d2929-7f78-cf63-e053-2995a90af82b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Northwind Health Company, LLC	f318d14a-9f96-4238-e053-2995a90abc15	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Northwind Health Company, LLC	f319e981-81ff-22da-e053-2a95a90a2738	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Northwind Health Company, LLC	d9cbda2a-70d9-74d3-e053-2a95a90aacc1	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	Northwind Health Company, LLC	d9df7d01-339c-8985-e053-2a95a90a0d2c	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Proficient Rx LP	0c8e58ab-c755-4560-b7f5-0dbd5e81a0b8	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	Coupler LLC	4616db7f-2c2f-96a5-e063-6394a90a939f	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATE	METOPROLOL TARTRATE	NuCare Pharmaceuticals, Inc.	4604cd40-f96f-42bf-e063-6294a90a308f	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: METOPROLOL TARTRATE generic name: METOPROLOL TARTRATE
Metoprolol Tartrate	METOPROLOL TARTRATE	QPharma Inc	2ad0606c-7a90-44bd-a75d-d256de30fbcf	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Metoprolol Tartrate generic name: METOPROLOL TARTRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10544-263	Metoprolol Tartrate	Metoprolol Tartrate	Blenheim Pharmacal, Inc.	ANDA	Current
48433-312	Metoprolol Tartrate	Metoprolol Tartrate	Safecor Health, LLC	ANDA	Current
66116-810	Metoprolol Tartrate	Metoprolol Tartrate	MedVantx, Inc.	ANDA	Current