Metoprolol Tartrate

Product NDC: 68083-131
11-digit product format: 680830131
Labeler code: 68083
Product ID: 68083-131_32f3e39e-0df1-4cd0-96f1-14d69d7b827d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Metoprolol Tartrate
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Gland Pharma Limited
Application: ANDA204205
Marketing category: ANDA
Marketing start: 2014-10-06
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Metoprolol Tartrate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METOPROLOL TARTRATE	5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W5S57Y3A5L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
866508	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e89cb5ec-e11b-4ca9-b3e3-34a4f144d7fe	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-131-01	Metoprolol Tartrate	5 mL in 1 VIAL, GLASS	INJECTION	5		5
68083-131-01	Metoprolol Tartrate	10 in 1 CARTON	INJECTION	10		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METOPROLOL TARTRATE	ACTIVE INGREDIENT	W5S57Y3A5L	METOPROLOL TARTRATE INJECTION [GLAND PHARMA LIMITED ]	3
METOPROLOL	ACTIVE MOIETY	GEB06NHM23	METOPROLOL TARTRATE INJECTION [GLAND PHARMA LIMITED ]	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	METOPROLOL TARTRATE INJECTION [GLAND PHARMA LIMITED ]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	METOPROLOL TARTRATE INJECTION [GLAND PHARMA LIMITED ]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-131	METOPROLOL TARTRATE INJECTION [GLAND PHARMA LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20201018_e89cb5ec-e11b-4ca9-b3e3-34a4f144d7fe.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 · 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 ndc (product): 68083-131

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
866508	metoprolol tartrate 5 MG in 5 ML Injection	PSN	e89cb5ec-e11b-4ca9-b3e3-34a4f144d7fe	5
866508	5 ML metoprolol tartrate 1 MG/ML Injection	SCD	e89cb5ec-e11b-4ca9-b3e3-34a4f144d7fe	5
866508	metoprolol tartrate 5 MG per 5 ML Injection	SY	e89cb5ec-e11b-4ca9-b3e3-34a4f144d7fe	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-131-01	68083013101	10 VIAL, GLASS in 1 CARTON (68083-131-01) / 5 mL in 1 VIAL, GLASS	2014-10-06	0000-00-00	No	No	Current