Isoproterenol Hydrochloride

Product NDC: 70860-306
Requested package NDC: 70860-306-02
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	70860-306-02	D	Discontinued by firm		2026-07-31

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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	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
2026-08-01 22:54:32	2026-06	A212189-001	AP	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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
70860-306-02	70860030602	10 VIAL in 1 CARTON (70860-306-02) > 1 mL in 1 VIAL (70860-306-41)	10 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