Metoprolol tartrate

Product NDC: 71610-443
11-digit product format: 716100443
Labeler code: 71610
Product ID: 71610-443_e8e90401-c593-4009-8954-89cb927d1430
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoprolol tartrate
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA074644
Marketing category: ANDA
Marketing start: 2015-06-29
Marketing end: 0000-00-00
Substance: METOPROLOL TARTRATE
Active strength: 50 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71610-443		D	Discontinued by firm	2026-08-17
excluded package	package	71610-443	71610-443-60	D	Discontinued by firm	2026-08-17
excluded package	package	71610-443	71610-443-70	D	Discontinued by firm	2026-08-17
excluded package	package	71610-443	71610-443-80	D	Discontinued by firm	2026-08-17
excluded package	package	71610-443	71610-443-92	D	Discontinued by firm	2026-08-17
excluded package	package	71610-443	71610-443-94	D	Discontinued by firm	2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A074644-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		1996-12-10
A074644-002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB		1996-12-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A074644-001	AB
A074644-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074644-001	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB	1996-12-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074644-002	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	1996-12-10	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074644-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074644-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074644-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074644-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074644-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074644-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074644-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074644-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074644-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074644-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074644-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074644-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074644-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074644-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074644-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074644-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074644-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074644-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074644-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074644-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074644-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074644-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074644-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074644-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074644-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074644-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074644-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074644-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074644-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074644-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074644-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074644-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074644-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074644-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074644-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074644-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074644-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074644-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074644-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074644-002	AB	1	`bb7c543d1eb4…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-443-60	EA - Each	71610-443	da580ada-a0e8-4674-a255-b2e8c6411852	1	2020-09-14
71610-443-70	EA - Each	71610-443	0e385a07-c1ec-44e1-831a-a5d0566cadd6	1	2021-04-08
71610-443-80	EA - Each	71610-443	4ef102df-4637-4380-ba90-ac0287bbfc2a	1	2020-09-14
71610-443-92	EA - Each	71610-443	f9999f89-7a62-44ff-bd64-b4cbd1f697e1	1	2020-09-14
71610-443-94	EA - Each	71610-443	6e713583-eab6-4dc4-b7ec-9c9f498e7b11	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-443	METOPROLOL TARTRATE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC	20210323_89b427c4-f479-4758-97b8-6214021d587e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W5S57Y3A5L	METOPROLOL TARTRATE	56392-17-7	METOPROLOL TARTRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-443-60	71610044360	90 TABLET in 1 BOTTLE (71610-443-60)	90 tablet	2020-07-07	0000-00-00	No	No	Current
71610-443-70	71610044370	120 TABLET in 1 BOTTLE (71610-443-70)	120 tablet	2020-01-06	0000-00-00	No	No	Current
71610-443-80	71610044380	180 TABLET in 1 BOTTLE (71610-443-80)	180 tablet	2020-07-07	0000-00-00	No	No	Current
71610-443-92	71610044392	270 TABLET in 1 BOTTLE (71610-443-92)	270 tablet	2020-07-07	0000-00-00	No	No	Current
71610-443-94	71610044394	360 TABLET in 1 BOTTLE (71610-443-94)	360 tablet	2021-02-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metoprolol Tartrate Tablets, USP Rx only	Aphena Pharma Solutions - Tennessee, LLC	2021-03-12	HUMAN PRESCRIPTION DRUG LABEL	3