Propranolol Hydrochloride

Product NDC: 70518-3552
11-digit product format: 705183552
Labeler code: 70518
Product ID: 70518-3552_4f58dd6f-ca42-9b96-e063-6394a90a5872
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: propranolol hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA212026
Marketing category: ANDA
Marketing start: 2022-10-09
Substance: PROPRANOLOL HYDROCHLORIDE
Active strength: 80 mg/1
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 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212026-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06
A212026-002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06
A212026-003	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06
A212026-004	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A212026-001	AB
A212026-002	AB
A212026-003	AB
A212026-004	AB

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 4 · 152 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	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212026-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212026-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212026-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212026-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-01-06	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 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	A212026-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212026-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212026-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212026-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212026-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212026-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212026-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212026-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212026-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212026-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212026-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212026-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212026-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212026-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212026-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212026-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212026-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212026-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212026-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212026-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212026-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212026-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212026-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212026-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212026-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212026-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212026-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212026-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212026-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212026-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212026-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212026-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212026-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212026-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212026-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212026-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212026-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212026-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212026-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212026-004	AB	1	`d8e5a09893c0…`

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	80 mg/1

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
856569	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
414c4b69-38a1-4220-bec8-204c9a624b85	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
70518-3552-0	Propranolol Hydrochloride	90 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	90		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3552	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.]	4	Current NDC, Legacy NDC, 1 package rows	20241121_414c4b69-38a1-4220-bec8-204c9a624b85.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 Hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	414c4b69-38a1-4220-bec8-204c9a624b85	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212026 application number: ANDA212026 ndc (product): 70518-3552
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	A-S Medication Solutions	87967c3a-4a6e-45c8-ae3d-1e1dbaa4ba10	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212026 application number: ANDA212026
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	ea98fedc-c440-487e-b144-35a8a389a446	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212026 application number: ANDA212026
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	b9d12ace-7e30-4183-99a4-c0a5a6a55cdf	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212026 application number: ANDA212026
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Lannett Company, Inc.	5229b561-287b-463c-8679-cda4c34f440b	2024-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212026 application number: ANDA212026

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
856569	propranolol HCl 80 MG 24HR Extended Release Oral Capsule	PSN	414c4b69-38a1-4220-bec8-204c9a624b85	6
856569	24 HR propranolol hydrochloride 80 MG Extended Release Oral Capsule	SCD	414c4b69-38a1-4220-bec8-204c9a624b85	6
856569	propranolol hydrochloride 80 MG 24 HR Extended Release Oral Capsule	SY	414c4b69-38a1-4220-bec8-204c9a624b85	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3552-0	70518355200	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3552-0)	2022-10-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Propranolol Hydrochloride Extended-Release Capsules, USP Rx only	REMEDYREPACK INC.	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	6