PROPRANOLOL

Product NDC: 0404-9999
11-digit product format: 004049999
Labeler code: 0404
Product ID: 0404-9999_a64c6dcb-7a81-4f7e-bd26-7ca72c56003b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: propranolol hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Henry Schein, Inc.
Application: ANDA075826
Marketing category: ANDA
Marketing start: 2024-07-15
Substance: PROPRANOLOL HYDROCHLORIDE
Active strength: 1 mg/mL
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 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
A075826-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP		2001-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075826-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075826-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075826-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075826-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075826-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075826-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075826-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075826-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075826-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075826-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075826-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075826-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075826-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075826-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075826-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075826-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075826-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075826-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075826-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075826-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075826-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075826-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075826-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075826-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075826-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075826-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075826-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075826-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075826-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075826-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075826-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075826-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075826-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075826-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075826-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075826-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075826-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075826-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075826-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075826-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075826-001	AP	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROPRANOLOL HYDROCHLORIDE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F8A3652H1V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856443	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
e586996d-9035-4ef4-8c8d-06e70a02577f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba1babb5-1c2a-d9a8-0fd7-8f90d4f768cf	Product name	2	20200609
a5696e6c-a559-4d6b-bb53-f324106f317c	Product name	1	20140718
0f446d3d-c9e6-1844-b8e8-a836dc35e0de	Product name	1	20140508
33a4b7b4-a3c1-3f95-a202-01166dd77c44	Product name	1	20140508
60519d27-227d-404a-38bc-37524c8b386b	Product name	1	20140508
d5f30598-8f94-b083-f161-65d67f2ae12a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0404-9999-01	PROPRANOLOL	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1		2
0404-9999-01	PROPRANOLOL	1 in 1 BAG	INJECTION, SOLUTION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9999	PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE) INJECTION, SOLUTION [HENRY SCHEIN, INC.]	1	Current NDC, 2 package rows	20240808_e586996d-9035-4ef4-8c8d-06e70a02577f.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROPRANOLOL	PROPRANOLOL	HF Acquisition Co LLC, DBA HealthFirst	54dd0fad-64ee-788f-e063-6394a90ac88e	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075826 application number: ANDA075826
Propranolol	PROPRANOLOL HYDROCHLORIDE	ProPharma Distribution	45b0aaf0-df6c-7db0-e063-6294a90a9135	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075826 application number: ANDA075826
PROPRANOLOL	PROPRANOLOL HYDROCHLORIDE	Henry Schein, Inc.	e586996d-9035-4ef4-8c8d-06e70a02577f	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075826 application number: ANDA075826 ndc (product): 0404-9999
Propranolol	PROPRANOLOL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9e50d1ee-b7f3-e549-e053-2995a90a4a86	2023-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075826 application number: ANDA075826
Propranolol	PROPRANOLOL HYDROCHLORIDE	Fresenius Kabi USA, LLC	f14ea537-dd5c-4c78-9037-9a85e9e610ef	2023-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075826 application number: ANDA075826

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F8A3652H1V	PROPRANOLOL HYDROCHLORIDE	318-98-9	PROPRANOLOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
856443	propranolol HCl 1 MG in 1 ML Injection	PSN	e586996d-9035-4ef4-8c8d-06e70a02577f	2
856443	1 ML propranolol hydrochloride 1 MG/ML Injection	SCD	e586996d-9035-4ef4-8c8d-06e70a02577f	2
856443	propranolol hydrochloride 1 MG per ML Injection	SY	e586996d-9035-4ef4-8c8d-06e70a02577f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0404-9999-01	00404999901	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9999-01) / 1 mL in 1 VIAL, SINGLE-DOSE	2024-07-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROPRANOLOL propranolol hydrochloride injection, solution Rx only	Henry Schein, Inc.	2025-11-07	HUMAN PRESCRIPTION DRUG LABEL	2