Propranolol Hydrochloride

Product NDC: 0054-3727
11-digit product format: 000543727
Labeler code: 0054
Product ID: 0054-3727_245a43cc-cbf8-486d-ad3c-724aca63fd72
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Propranolol Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA070979
Marketing category: ANDA
Marketing start: 1987-05-15
Substance: PROPRANOLOL HYDROCHLORIDE
Active strength: 20 mg/5mL
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.

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROPRANOLOL HYDROCHLORIDE	20 mg/5mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856724	Internal RxNorm lookup
856733	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
8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	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
0054-3727-63	Propranolol Hydrochloride	500 mL in 1 BOTTLE, PLASTIC	SOLUTION	500		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-3727-63	ML - Milliliter	0054-3727	8f449ee4-5248-40cd-8d8d-c102d1a34d0f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROPRANOLOL HYDROCHLORIDE	ACTIVE INGREDIENT	F8A3652H1V	PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	6
PROPRANOLOL	ACTIVE MOIETY	9Y8NXQ24VQ	PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	6
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	6
EDETATE CALCIUM DISODIUM	INACTIVE INGREDIENT	25IH6R4SGF	PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	6
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	6
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	6
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	6
SORBITOL	INACTIVE INGREDIENT	506T60A25R	PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-3727	PROPRANOLOL HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	11	Current NDC, Legacy NDC, 1 package rows	20241206_8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	b609cc7c-1f6a-452b-8ada-c4d2989b83dc	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070979 application number: ANDA070979
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e	2026-06-26	Warnings, Adverse reactions	Exact identifier ndc (product): 0054-3727
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	40333bee-749f-0b43-e063-6394a90a149c	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070979 application number: ANDA070979
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ec5c919b-05d1-45d2-a6e4-ac4ae1101dbb	2022-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070979 application number: ANDA070979

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
856724	propranolol HCl 20 MG in 5 mL Oral Solution	PSN	8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e	11
856733	propranolol HCl 40 MG in 5 mL Oral Solution	PSN	8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e	11
856724	propranolol hydrochloride 4 MG/ML Oral Solution	SCD	8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e	11
856733	propranolol hydrochloride 8 MG/ML Oral Solution	SCD	8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e	11
856724	propranolol hydrochloride 20 MG per 5 ML Oral Solution	SY	8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e	11
856733	propranolol hydrochloride 40 MG per 5 ML Oral Solution	SY	8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e	11
856724	propranolol HCl 20 MG in 5 mL Oral Solution	PSN	b609cc7c-1f6a-452b-8ada-c4d2989b83dc	5
856724	propranolol hydrochloride 4 MG/ML Oral Solution	SCD	b609cc7c-1f6a-452b-8ada-c4d2989b83dc	5
856724	propranolol hydrochloride 20 MG per 5 ML Oral Solution	SY	b609cc7c-1f6a-452b-8ada-c4d2989b83dc	5
856724	propranolol HCl 20 MG in 5 mL Oral Solution	PSN	ec5c919b-05d1-45d2-a6e4-ac4ae1101dbb	4
856724	propranolol hydrochloride 4 MG/ML Oral Solution	SCD	ec5c919b-05d1-45d2-a6e4-ac4ae1101dbb	4
856724	propranolol hydrochloride 20 MG per 5 ML Oral Solution	SY	ec5c919b-05d1-45d2-a6e4-ac4ae1101dbb	4
856724	propranolol HCl 20 MG in 5 mL Oral Solution	PSN	73124cb1-3763-49b0-8317-e30705048053	2
856724	propranolol HCl 20 MG in 5 mL Oral Solution	PSN	2f69cab3-e04d-44ab-adb6-9d01169f4f00	2
856724	propranolol hydrochloride 4 MG/ML Oral Solution	SCD	73124cb1-3763-49b0-8317-e30705048053	2
856724	propranolol hydrochloride 4 MG/ML Oral Solution	SCD	2f69cab3-e04d-44ab-adb6-9d01169f4f00	2
856724	propranolol hydrochloride 20 MG per 5 ML Oral Solution	SY	73124cb1-3763-49b0-8317-e30705048053	2
856724	propranolol hydrochloride 20 MG per 5 ML Oral Solution	SY	2f69cab3-e04d-44ab-adb6-9d01169f4f00	2
856724	propranolol HCl 20 MG in 5 mL Oral Solution	PSN	40333bee-749f-0b43-e063-6394a90a149c	1
856724	propranolol hydrochloride 4 MG/ML Oral Solution	SCD	40333bee-749f-0b43-e063-6394a90a149c	1
856724	propranolol hydrochloride 20 MG per 5 ML Oral Solution	SY	40333bee-749f-0b43-e063-6394a90a149c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-3727-63	00054372763	500 mL in 1 BOTTLE, PLASTIC (0054-3727-63)	500 ml	1987-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Propanolol Hydrochloride Oral Solution	ATLANTIC BIOLOGICALS CORP.	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	6
Propranolol Hydrochloride Oral Solution	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2026-06-26	HUMAN PRESCRIPTION DRUG LABEL	12
Propanolol Hydrochloride Oral Solution	ATLANTIC BIOLOGICALS CORP.	2025-10-01	HUMAN PRESCRIPTION DRUG LABEL	1
Propranolol Hydrochloride Oral Solution	Pharmaceutical Associates, Inc.	2022-06-22	HUMAN PRESCRIPTION DRUG LABEL	4
Propanolol Hydrochloride Oral Solution	Carilion Materials Management	2017-12-28	HUMAN PRESCRIPTION DRUG LABEL	2
PROPRANOLOL HYDROCHLORIDE Oral Solution 20 mg per 5 mL and 40 mg per 5 mL	Carilion Materials Management	2012-02-01	HUMAN PRESCRIPTION DRUG LABEL	2