Metoprolol Tartrate

Product NDC: 53808-0382
11-digit product format: 538080382
Labeler code: 53808
Product ID: 53808-0382_f59d2f6d-b2ff-418e-92fc-e00ccd7d63ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metoprolol tartrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA076704
Marketing category: ANDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: METOPROLOL TARTRATE
Active strength: 25 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-0382		I	Inactivated by FDA		2026-08-07
excluded package	package	53808-0382	53808-0382-1	I	Inactivated by FDA		2026-08-07

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 · 44 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	53808-0382-1	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	53808-0382-1	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	53808-0382-1	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	53808-0382-1	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	53808-0382-1	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	53808-0382-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0382-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0382-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0382-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0382-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0382-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0382-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0382-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0382-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0382-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0382-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0382-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0382-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0382-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0382-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0382-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53808-0382-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076704-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16
A076704-002	METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16
A076704-003	METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16
A076704-004	METOPROLOL TARTRATE	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18
A076704-005	METOPROLOL TARTRATE	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A076704-001	AB
A076704-002	AB
A076704-003	AB
A076704-004	AB
A076704-005	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 6 · 205 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	A076704-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076704-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076704-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076704-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076704-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076704-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076704-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076704-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076704-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076704-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-001	METOPROLOL TARTRATE	25MG	TABLET / ORAL	AB		2004-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-002	METOPROLOL TARTRATE	50MG	TABLET / ORAL	AB		2004-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-003	METOPROLOL TARTRATE	100MG	TABLET / ORAL	AB	RS	2004-01-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-004	METOPROLOL TARTRATE	37.5MG	TABLET / ORAL	AB		2015-03-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-005	METOPROLOL TARTRATE	75MG	TABLET / ORAL	AB		2015-03-18	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 201 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	A076704-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076704-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076704-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076704-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076704-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076704-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076704-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076704-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076704-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076704-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076704-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076704-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076704-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076704-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076704-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076704-005	AB	1	`5bbf6a4d5a75…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0382-1	2020-01-31	C162847	48780-1	9d75b9d1-0d8f-f424-e053-dadaa90a57ce	17ed5d5c-074f-4a59-bde6-209b3df87221

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0382-1	Metoprolol Tartrate	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METOPROLOL TARTRATE	ACTIVE INGREDIENT	W5S57Y3A5L	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
METOPROLOL	ACTIVE MOIETY	GEB06NHM23	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0382	METOPROLOL TARTRATE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20100901_17ed5d5c-074f-4a59-bde6-209b3df87221.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	cbcec1e7-7eac-456e-a253-aaf6761b4883	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704
Metoprolol Tartrate	METOPROLOL TARTRATE	Cardinal Health 107, LLC	0ccb9d3c-3f9a-486d-9b27-dc6f3ef6f4ed	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704
Metoprolol Tartrate	METOPROLOL TARTRATE	Safecor Health, LLC	63d45147-9b37-40e2-9619-cd1a3e77ff31	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704
Metoprolol Tartrate	METOPROLOL TARTRATE	PD-Rx Pharmaceuticals, Inc.	ab44f4c5-9497-4c92-8545-e4718ddb8f08	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704
Metoprolol Tartrate	METOPROLOL TARTRATE	Mylan Institutional Inc.	961248d5-d53c-408d-8f8f-d31885054f96	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704
Metoprolol Tartrate	METOPROLOL TARTRATE	Cardinal Health 107, LLC	6399f2c3-7799-4f8b-b8b7-8d2137b1f852	2025-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704
Metoprolol Tartrate	METOPROLOL TARTRATE	Golden State Medical Supply, Inc.	bec7ccad-00ad-4a3b-e053-2995a90ae3d8	2024-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704
Metoprolol Tartrate	METOPROLOL TARTRATE	Mylan Pharmaceuticals Inc.	809c6386-0039-42ff-a03e-e42733e229b8	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704
Metoprolol Tartrate	METOPROLOL TARTRATE	Aphena Pharma Solutions - Tennessee, LLC	ea141b60-b08e-4f0f-9f29-cd765f4d7ca6	2022-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076704 application number: ANDA076704

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866511	metoprolol tartrate 100 MG Oral Tablet	PSN	17ed5d5c-074f-4a59-bde6-209b3df87221	1
866924	metoprolol tartrate 25 MG Oral Tablet	PSN	17ed5d5c-074f-4a59-bde6-209b3df87221	1
866514	metoprolol tartrate 50 MG Oral Tablet	PSN	17ed5d5c-074f-4a59-bde6-209b3df87221	1
866511	metoprolol tartrate 100 MG Oral Tablet	SCD	17ed5d5c-074f-4a59-bde6-209b3df87221	1
866924	metoprolol tartrate 25 MG Oral Tablet	SCD	17ed5d5c-074f-4a59-bde6-209b3df87221	1
866514	metoprolol tartrate 50 MG Oral Tablet	SCD	17ed5d5c-074f-4a59-bde6-209b3df87221	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0382-1	53808038201	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metoprolol Tartrate - State of Florida DOH Central Pharmacy	State of Florida DOH Central Pharmacy	2010-08-13	HUMAN PRESCRIPTION DRUG LABEL	1