Metoprolol Tartrate

Product NDC: 70860-300
Requested package NDC: 70860-300-05
11-digit product format: 708600300
Labeler code: 70860
Product ID: 70860-300_d02e25f4-72ce-441e-839a-aaf0c6416f34
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: metoprolol tartrate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Athenex Pharmaceutical Division, LLC.
Application: ANDA204205
Marketing category: ANDA
Marketing start: 2017-01-01
Marketing end: 2022-04-30
Substance: METOPROLOL TARTRATE
Active strength: 5 mg/5mL
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70860-300	70860-300-05	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204205-001	METOPROLOL TARTRATE	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP		2014-08-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204205-001	AP

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204205-001	METOPROLOL TARTRATE	1MG/ML	INJECTABLE / INJECTION	AP	2014-08-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A204205-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204205-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204205-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204205-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204205-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204205-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204205-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204205-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204205-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204205-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204205-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204205-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204205-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204205-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204205-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204205-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204205-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204205-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204205-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204205-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204205-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204205-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204205-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204205-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204205-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204205-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204205-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204205-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204205-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204205-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204205-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204205-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204205-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204205-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204205-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204205-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204205-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204205-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204205-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204205-001	AP	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70860-300-05	ML - Milliliter	70860-300	622c0357-8763-4b5d-a63c-246a88284e99	1	2017-03-06
70860-300-41	ML - Milliliter	70860-300	0e76d91f-e130-461b-972d-ca57fb3c9314	1	2019-04-11

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metoprolol Tartrate	METOPROLOL TARTRATE	Cardinal Health 107, LLC	e93d7939-31ad-4fc5-a5f3-6d565cc6d0c1	2025-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204205 application number: ANDA204205
Metoprolol Tartrate	METOPROLOL TARTRATE	FOSUN PHARMA USA INC	1e787808-b3e0-417a-b333-80619d15432b	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204205 application number: ANDA204205
Metoprolol Tartrate	METOPROLOL TARTRATE	Almaject, Inc.	f0370951-ab26-d4d1-b857-57518f3c4175	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204205 application number: ANDA204205
Metoprolol Tartrate	METOPROLOL TARTRATE	Sagent Pharmaceuticals	f3817543-544a-4afa-ac7c-c1b48c1307c2	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204205 application number: ANDA204205
Metoprolol Tartrate	METOPROLOL TARTRATE	Medical Purchasing Solutions, LLC	b632f750-14a0-d27f-e053-2a95a90a1df3	2023-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204205 application number: ANDA204205
Metoprolol Tartrate	METOPROLOL TARTRATE	Medical Purchasing Solutions, LLC	dc667cfc-b344-2ba4-e053-2a95a90a3bb9	2023-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204205 application number: ANDA204205
Metoprolol Tartrate	METOPROLOL TARTRATE	Gland Pharma Limited	e89cb5ec-e11b-4ca9-b3e3-34a4f144d7fe	2020-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204205 application number: ANDA204205

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	Marketing start	Marketing end	Sample	Exclude flag	Status
70860-300-05	70860030005	10 VIAL, SINGLE-DOSE in 1 CARTON (70860-300-05) > 5 mL in 1 VIAL, SINGLE-DOSE (70860-300-41)	2017-01-01	2022-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Metoprolol Tartrate	Athenex Pharmaceutical Division, LLC.	2022-02-17	HUMAN PRESCRIPTION DRUG LABEL	6