Isoproterenol Hydrochloride

Product NDC: 70860-306
Requested package NDC: 70860-306-01
11-digit product format: 708600306
Labeler code: 70860
Product ID: 70860-306_e4d32d21-a9e7-4ddc-a2ef-de0a1f8c4bbf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: isoproterenol hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Athenex Pharmaceutical Division, LLC.
Application: ANDA212189
Marketing category: ANDA
Marketing start: 2022-12-13
Marketing end: 0000-00-00
Substance: ISOPROTERENOL HYDROCHLORIDE
Active strength: 0 mg/mL
Pharmacologic classes: Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70860-306	70860-306-01	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 · 11 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…`

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
A212189-001	ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP		2021-11-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212189-001	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
2026-02-19 14:30 UTC	2026-02	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212189-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2021-11-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212189-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212189-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212189-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212189-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212189-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212189-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212189-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212189-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212189-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212189-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212189-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212189-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212189-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212189-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212189-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212189-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212189-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212189-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212189-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212189-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212189-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212189-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212189-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212189-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212189-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212189-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212189-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212189-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212189-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212189-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212189-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212189-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212189-001	AP	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70860-306-02	ML - Milliliter	70860-306	9e21fa10-5dc5-4d24-aa33-575ed43cdc6f	1	2024-05-16

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	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	d140b27a-3bf7-4e0f-bb91-02b588184f52	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212189 application number: ANDA212189
Isoproterenol Hydrochloride	ISOPROTERENOL HYDROCHLORIDE	Avenacy, Inc.	212af0f4-42c7-425d-8baf-9a2f594289a2	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212189 application number: ANDA212189

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70860-306-01	70860030601	5 VIAL in 1 CARTON (70860-306-01) > 1 mL in 1 VIAL (70860-306-41)	5 vial	2022-12-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isoproterenol Hydrochloride Injection, USP Sterile Injection	Athenex Pharmaceutical Division, LLC. \| Emcure Pharmaceuticals Limited	2023-11-22	HUMAN PRESCRIPTION DRUG LABEL	2