PROPRANOLOL

Product NDC: 51662-1700
11-digit product format: 516621700
Labeler code: 51662
Product ID: 51662-1700_54dd0fad-64ef-788f-e063-6394a90ac88e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROPRANOLOL
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA075826
Marketing category: ANDA
Marketing start: 2001-09-07
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A075826-001	PROPRANOLOL HYDROCHLORIDE	1MG/ML	INJECTABLE / INJECTION	AP	2001-08-31	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075826-001	AP	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: PROPRANOLOL
Listing expiration: 2027-12-31

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
54dd0fad-64ee-788f-e063-6394a90ac88e	Available on FDA.report

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 ndc (product): 51662-1700
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
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
9Y8NXQ24VQ	PROPRANOLOL	525-66-6	PROPRANOLOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51662-1700-1	51662170001	1 mL in 1 VIAL, SINGLE-DOSE (51662-1700-1)	1 ml	2001-09-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROPRANOLOL - HF Acquisition Co LLC, DBA HealthFirst	HF Acquisition Co LLC, DBA HealthFirst	2026-06-22	HUMAN PRESCRIPTION DRUG LABEL	1