Propranolol Hydrochloride

Product NDC: 0121-0908
11-digit product format: 001210908
Labeler code: 0121
Product ID: 0121-0908_e20b8c76-152c-9fee-e053-2a95a90aa52d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Propranolol Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Pharmaceutical Associates, Inc.
Application: ANDA070979
Marketing category: ANDA
Marketing start: 2021-09-03
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: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856724	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
ec5c919b-05d1-45d2-a6e4-ac4ae1101dbb	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	SPL version
0121-0908-05	Propranolol Hydrochloride	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	4
0121-0908-40	Propranolol Hydrochloride	4 in 1 CASE	SOLUTION	4	4
0121-0908-40	Propranolol Hydrochloride	10 in 1 TRAY	SOLUTION	10	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0908-05	ML - Milliliter	0121-0908	0c98026a-2ac3-4103-8296-2687f42991fd	1	2021-11-09
0121-0908-40	ML - Milliliter	0121-0908	0dec7d61-3033-478b-be0a-d4c02acfe3ba	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0908	PROPRANOLOL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]	4	Current NDC, Legacy NDC, 3 package rows	20220624_ec5c919b-05d1-45d2-a6e4-ac4ae1101dbb.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 · 3 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	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 ndc (product): 0121-0908

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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-0908-05	00121090805	5 mL in 1 CUP, UNIT-DOSE	5 ml					Historical
0121-0908-40	00121090840	4 TRAY in 1 CASE (0121-0908-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0908-05)	4 tray	2021-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Propranolol Hydrochloride Oral Solution	Pharmaceutical Associates, Inc.	2022-06-22	HUMAN PRESCRIPTION DRUG LABEL	4