Isoproterenol Hydrochloride

Product NDC: 72485-113
11-digit product format: 724850113
Labeler code: 72485
Product ID: 72485-113_f62c3ef7-c8bd-4517-8ca9-b22829516dbf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isoproterenol Hydrochloride
Dosage form: INJECTION
Route: INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Armas Pharmaceuticals Inc.
Application: ANDA210845
Marketing category: ANDA
Marketing start: 2021-08-06
Substance: ISOPROTERENOL HYDROCHLORIDE
Active strength: .2 mg/mL
Pharmacologic classes: Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [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 42.

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
A210845-001	ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP		2021-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210845-001	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.

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	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210845-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-02-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210845-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210845-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210845-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210845-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210845-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210845-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210845-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210845-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210845-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210845-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210845-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210845-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210845-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210845-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210845-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210845-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210845-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210845-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210845-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210845-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210845-001	AP	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210845-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210845-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210845-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210845-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210845-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210845-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210845-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210845-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210845-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210845-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210845-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210845-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210845-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210845-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Isoproterenol Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ISOPROTERENOL HYDROCHLORIDE	.2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
DIA2A74855	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1667915	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
56cb205c-8329-454a-a6be-e05e497de81e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7757a57a-4dcc-4536-b5df-2fed4aa930c9	Product name	9	20240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72485-113-10	2023-08-01	C162847	48780-1	f386c64a-1d32-0266-e053-dadaa90a7c1a	Rx only These highlights do not include all the information needed to use ISOPROTERENOL HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for ISOPROTERENOL HYDROCHLORIDE INJECTION. ISOPROTERENOL HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1956
72485-113-10	2023-01-30	C162847	48780-1	f386c64a-1d32-0266-e053-dadaa90a7c1a	Rx only These highlights do not include all the information needed to use ISOPROTERENOL HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for ISOPROTERENOL HYDROCHLORIDE INJECTION. ISOPROTERENOL HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1956

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72485-113-01	Isoproterenol Hydrochloride	5 mL in 1 AMPULE	INJECTION	5		2
72485-113-10	Isoproterenol Hydrochloride	10 in 1 CARTON	INJECTION	10		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72485-113-01	ML - Milliliter	72485-113	e8ac61fe-4ded-496c-9721-9fb684602177	1	2021-09-07
72485-113-10	ML - Milliliter	72485-113	c4182b2b-f835-4b8a-8cfc-4db54eb16524	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72485-113	ISOPROTERENOL HYDROCHLORIDE INJECTION [ARMAS PHARMACEUTICALS INC.]	2	Current NDC, Legacy NDC, 2 package rows	20230802_56cb205c-8329-454a-a6be-e05e497de81e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isoproterenol Hydrochloride	ISOPROTERENOL HYDROCHLORIDE	Armas Pharmaceuticals Inc.	56cb205c-8329-454a-a6be-e05e497de81e	2023-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210845 application number: ANDA210845 ndc (product): 72485-113
Isoproterenol Hydrochloride	ISOPROTERENOL HYDROCHLORIDE	Micro Labs Limited	0f6a7651-e7b4-4ada-8ccd-2123d094a113	2022-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210845 application number: ANDA210845

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
DIA2A74855	ISOPROTERENOL HYDROCHLORIDE	51-30-9	ISOPROTERENOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1667915	isoproterenol 1 MG in 5 ML Injection	PSN	56cb205c-8329-454a-a6be-e05e497de81e	2
1667915	5 ML isoproterenol hydrochloride 0.2 MG/ML Injection	SCD	56cb205c-8329-454a-a6be-e05e497de81e	2
1667915	isoproterenol 1 MG per 5 ML Injection	SY	56cb205c-8329-454a-a6be-e05e497de81e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72485-113-01	72485011301	5 mL in 1 AMPULE	5 ml					Historical
72485-113-10	72485011310	10 AMPULE in 1 CARTON (72485-113-10) / 5 mL in 1 AMPULE (72485-113-01)	10 ampule	2021-08-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isoproterenol Hydrochloride	Armas Pharmaceuticals Inc.	2023-07-27	HUMAN PRESCRIPTION DRUG LABEL	2