Isoproterenol Hydrochloride

Product NDC: 54879-039
Requested package NDC: 54879-039-15
11-digit product format: 548790039
Labeler code: 54879
Product ID: 54879-039_128fbb7d-c4ea-4d76-9592-09affa631bf6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Isoproterenol Hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRACARDIAC; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: STI Pharma LLC
Application: ANDA215542
Marketing category: ANDA
Marketing start: 2022-12-15
Marketing end: 0000-00-00
Substance: ISOPROTERENOL HYDROCHLORIDE
Active strength: 1 mg/5mL
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	54879-039	54879-039-15	I	Inactivated by FDA		2026-08-17

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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A215542-001	ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP		2022-09-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215542-001	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	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215542-001	ISOPROTERENOL HYDROCHLORIDE	0.2MG/ML	INJECTABLE / INJECTION	AP	2022-09-20	`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	A215542-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215542-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215542-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215542-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215542-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215542-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215542-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215542-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215542-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215542-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215542-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215542-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215542-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215542-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215542-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215542-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215542-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215542-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215542-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215542-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215542-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215542-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215542-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215542-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215542-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215542-001	AP	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215542-001	AP	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7757a57a-4dcc-4536-b5df-2fed4aa930c9	Product name	9	20240506
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54879-039-15	2024-01-30	C162847	48780-1	1030e365-5062-111a-e063-dadaa90a10e2	Isoproterenol Hydrochloride Injection, USP Sterile Injection Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54879-039-15	Isoproterenol Hydrochloride	10 in 1 CARTON	INJECTION, SOLUTION	10		1
54879-039-15	Isoproterenol Hydrochloride	5 mL in 1 VIAL	INJECTION, SOLUTION	5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54879-039	ISOPROTERENOL HYDROCHLORIDE INJECTION, SOLUTION [STI PHARMA LLC]	1	Legacy NDC, 2 package rows	20221217_1afd7fc5-25c9-4796-b376-081b20de8ab3.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isoproterenol hydrochloride	ISOPROTERENOL HYDROCHLORIDE	KVK-Tech, Inc.	051acbc2-7bf8-4059-e063-6394a90a115b	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215542 application number: ANDA215542

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	1afd7fc5-25c9-4796-b376-081b20de8ab3	1
1667915	5 ML isoproterenol hydrochloride 0.2 MG/ML Injection	SCD	1afd7fc5-25c9-4796-b376-081b20de8ab3	1
1667915	isoproterenol 1 MG per 5 ML Injection	SY	1afd7fc5-25c9-4796-b376-081b20de8ab3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54879-039-15	54879003915	10 VIAL in 1 CARTON (54879-039-15) > 5 mL in 1 VIAL	10 vial	2022-12-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isoproterenol Hydrochloride Injection, USP Sterile Injection Rx only	STI Pharma LLC \| Immacule Lifesciences Private Limited	2022-10-03	HUMAN PRESCRIPTION DRUG LABEL	1