propranolol hydrochloride

Product NDC: 51991-819
11-digit product format: 519910819
Labeler code: 51991
Product ID: 51991-819_f7b4203a-c93c-47a2-9ad0-41df7d7a2c26
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: propranolol hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Breckenridge Pharmaceutical, Inc.
Application: ANDA078703
Marketing category: ANDA
Marketing start: 2013-03-11
Substance: PROPRANOLOL HYDROCHLORIDE
Active strength: 120 mg/1
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078703-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15
A078703-002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15
A078703-003	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15
A078703-004	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078703-001	AB
A078703-002	AB
A078703-003	AB
A078703-004	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 5 · 168 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	A078703-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078703-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078703-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078703-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078703-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078703-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078703-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078703-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078703-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078703-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078703-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078703-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078703-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078703-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078703-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078703-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078703-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078703-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078703-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078703-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078703-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078703-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078703-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078703-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078703-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078703-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078703-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078703-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078703-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078703-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078703-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078703-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078703-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078703-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078703-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078703-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078703-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078703-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078703-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078703-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-07-15	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A078703-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078703-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078703-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078703-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078703-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078703-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078703-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078703-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078703-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078703-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078703-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078703-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078703-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078703-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078703-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078703-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078703-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078703-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078703-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078703-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078703-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078703-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078703-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078703-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078703-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078703-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078703-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078703-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078703-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078703-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078703-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078703-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078703-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078703-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078703-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078703-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078703-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078703-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078703-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078703-004	AB	1	`d8e5a09893c0…`

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	120 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856460	Internal RxNorm lookup
856481	Internal RxNorm lookup
856535	Internal RxNorm lookup
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
179e31a7-9956-4fba-9e9a-2ca28d37d42b	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
51991-819-01	propranolol hydrochloride	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		11
51991-819-05	propranolol hydrochloride	500 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	500		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51991-819-01	EA - Each	51991-819	2ed1a044-3ef3-41d4-bf77-14291b75a895	1	2013-04-01
51991-819-05	EA - Each	51991-819	b90ba6b6-46f4-4872-bb96-4e5d9ac79e4e	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
propranolol hydrochloride	ACTIVE INGREDIENT	F8A3652H1V	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3
propranolol	ACTIVE MOIETY	9Y8NXQ24VQ	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3
ammonia	INACTIVE INGREDIENT	5138Q19F1X	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3
diethyl phthalate	INACTIVE INGREDIENT	UF064M00AF	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3
ethylcellulose (10 MPA.S)	INACTIVE INGREDIENT	3DYK7UYZ62	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3
gelatin	INACTIVE INGREDIENT	2G86QN327L	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3
hypromellose phthalate (24% phthalate, 55 CST)	INACTIVE INGREDIENT	87Y6436BKR	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3
povidone K29/32	INACTIVE INGREDIENT	390RMW2PEQ	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3
sucrose	INACTIVE INGREDIENT	C151H8M554	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51991-819	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRECKENRIDGE PHARMACEUTICAL, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20240327_179e31a7-9956-4fba-9e9a-2ca28d37d42b.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	4803b5bf-8ca4-4a8b-bd24-1f3ff7d93d7e	2026-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	14957737-4e53-cc6d-e063-6294a90a181e	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	36230aaa-b6e5-4ebb-e063-6294a90ac3b9	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	AvKARE	753ab3cb-e7ee-424b-aa7d-195b5871a40e	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	REMEDYREPACK INC.	e0241448-5727-4c68-ae2a-6f41cd962d7c	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	1aedd4d5-fe70-4cb0-9d6d-d2bd241ebaa6	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	96fa108c-b31c-445c-b978-c848cac59419	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	5cf8d0a4-4e02-48f0-8d1f-564357b250c5	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	e0959293-321d-4427-8bb7-8e74b03464d6	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	American Health Packaging	015b5e4f-3228-4259-b419-e0e49694a058	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	82a4d30b-5018-453d-a8ab-fef2e3266f69	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	c5ad5449-b93e-4f26-977b-c66466d8ac6f	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Breckenridge Pharmaceutical, Inc.	179e31a7-9956-4fba-9e9a-2ca28d37d42b	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703 ndc (product): 51991-819
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	5ee3776f-9d02-4d98-bc9d-e810c87961c3	2024-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	0e185e88-cea2-4d01-8711-67317247fd25	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	44a7900c-b240-4e04-954e-2671d4d51ae7	2024-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	8e675a00-2b20-4fcd-baa0-661bcf9809c8	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	Proficient Rx LP	1d7c1de3-3cf4-4b1e-bdcc-55f423c88001	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703
propranolol hydrochloride	PROPRANOLOL HYDROCHLORIDE	A-S Medication Solutions	d1cfdb57-0b04-43f7-bd10-c585f77385b3	2023-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078703 application number: ANDA078703

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
856460	propranolol HCl 120 MG 24HR Extended Release Oral Capsule	PSN	0e185e88-cea2-4d01-8711-67317247fd25	105
856460	24 HR propranolol hydrochloride 120 MG Extended Release Oral Capsule	SCD	0e185e88-cea2-4d01-8711-67317247fd25	105
856460	propranolol hydrochloride 120 MG 24 HR Extended Release Oral Capsule	SY	0e185e88-cea2-4d01-8711-67317247fd25	105
856460	propranolol HCl 120 MG 24HR Extended Release Oral Capsule	PSN	96fa108c-b31c-445c-b978-c848cac59419	102
856460	propranolol HCl 120 MG 24HR Extended Release Oral Capsule	PSN	c5ad5449-b93e-4f26-977b-c66466d8ac6f	102
856460	24 HR propranolol hydrochloride 120 MG Extended Release Oral Capsule	SCD	96fa108c-b31c-445c-b978-c848cac59419	102
856460	24 HR propranolol hydrochloride 120 MG Extended Release Oral Capsule	SCD	c5ad5449-b93e-4f26-977b-c66466d8ac6f	102
856460	propranolol hydrochloride 120 MG 24 HR Extended Release Oral Capsule	SY	c5ad5449-b93e-4f26-977b-c66466d8ac6f	102
856460	propranolol hydrochloride 120 MG 24 HR Extended Release Oral Capsule	SY	96fa108c-b31c-445c-b978-c848cac59419	102
856460	propranolol HCl 120 MG 24HR Extended Release Oral Capsule	PSN	e0241448-5727-4c68-ae2a-6f41cd962d7c	14
856460	24 HR propranolol hydrochloride 120 MG Extended Release Oral Capsule	SCD	e0241448-5727-4c68-ae2a-6f41cd962d7c	14
856460	propranolol hydrochloride 120 MG 24 HR Extended Release Oral Capsule	SY	e0241448-5727-4c68-ae2a-6f41cd962d7c	14
856460	propranolol HCl 120 MG 24HR Extended Release Oral Capsule	PSN	179e31a7-9956-4fba-9e9a-2ca28d37d42b	11
856481	propranolol HCl 160 MG 24HR Extended Release Oral Capsule	PSN	179e31a7-9956-4fba-9e9a-2ca28d37d42b	11
856535	propranolol HCl 60 MG 24HR Extended Release Oral Capsule	PSN	179e31a7-9956-4fba-9e9a-2ca28d37d42b	11
856569	propranolol HCl 80 MG 24HR Extended Release Oral Capsule	PSN	179e31a7-9956-4fba-9e9a-2ca28d37d42b	11
856460	24 HR propranolol hydrochloride 120 MG Extended Release Oral Capsule	SCD	179e31a7-9956-4fba-9e9a-2ca28d37d42b	11
856481	24 HR propranolol hydrochloride 160 MG Extended Release Oral Capsule	SCD	179e31a7-9956-4fba-9e9a-2ca28d37d42b	11
856535	24 HR propranolol hydrochloride 60 MG Extended Release Oral Capsule	SCD	179e31a7-9956-4fba-9e9a-2ca28d37d42b	11
856569	24 HR propranolol hydrochloride 80 MG Extended Release Oral Capsule	SCD	179e31a7-9956-4fba-9e9a-2ca28d37d42b	11
856460	propranolol hydrochloride 120 MG 24 HR Extended Release Oral Capsule	SY	179e31a7-9956-4fba-9e9a-2ca28d37d42b	11
856481	propranolol hydrochloride 160 MG 24 HR Extended Release Oral Capsule	SY	179e31a7-9956-4fba-9e9a-2ca28d37d42b	11
856535	propranolol hydrochloride 60 MG 24 HR Extended Release Oral Capsule	SY	179e31a7-9956-4fba-9e9a-2ca28d37d42b	11
856569	propranolol hydrochloride 80 MG 24 HR Extended Release Oral Capsule	SY	179e31a7-9956-4fba-9e9a-2ca28d37d42b	11
856460	propranolol HCl 120 MG 24HR Extended Release Oral Capsule	PSN	753ab3cb-e7ee-424b-aa7d-195b5871a40e	9
856481	propranolol HCl 160 MG 24HR Extended Release Oral Capsule	PSN	753ab3cb-e7ee-424b-aa7d-195b5871a40e	9
856535	propranolol HCl 60 MG 24HR Extended Release Oral Capsule	PSN	753ab3cb-e7ee-424b-aa7d-195b5871a40e	9
856569	propranolol HCl 80 MG 24HR Extended Release Oral Capsule	PSN	753ab3cb-e7ee-424b-aa7d-195b5871a40e	9
856460	24 HR propranolol hydrochloride 120 MG Extended Release Oral Capsule	SCD	753ab3cb-e7ee-424b-aa7d-195b5871a40e	9
856481	24 HR propranolol hydrochloride 160 MG Extended Release Oral Capsule	SCD	753ab3cb-e7ee-424b-aa7d-195b5871a40e	9
856535	24 HR propranolol hydrochloride 60 MG Extended Release Oral Capsule	SCD	753ab3cb-e7ee-424b-aa7d-195b5871a40e	9
856569	24 HR propranolol hydrochloride 80 MG Extended Release Oral Capsule	SCD	753ab3cb-e7ee-424b-aa7d-195b5871a40e	9
856460	propranolol hydrochloride 120 MG 24 HR Extended Release Oral Capsule	SY	753ab3cb-e7ee-424b-aa7d-195b5871a40e	9
856481	propranolol hydrochloride 160 MG 24 HR Extended Release Oral Capsule	SY	753ab3cb-e7ee-424b-aa7d-195b5871a40e	9
856535	propranolol hydrochloride 60 MG 24 HR Extended Release Oral Capsule	SY	753ab3cb-e7ee-424b-aa7d-195b5871a40e	9
856569	propranolol hydrochloride 80 MG 24 HR Extended Release Oral Capsule	SY	753ab3cb-e7ee-424b-aa7d-195b5871a40e	9
856460	propranolol HCl 120 MG 24HR Extended Release Oral Capsule	PSN	e0959293-321d-4427-8bb7-8e74b03464d6	1
856460	24 HR propranolol hydrochloride 120 MG Extended Release Oral Capsule	SCD	e0959293-321d-4427-8bb7-8e74b03464d6	1
856460	propranolol hydrochloride 120 MG 24 HR Extended Release Oral Capsule	SY	e0959293-321d-4427-8bb7-8e74b03464d6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51991-819-01	51991081901	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51991-819-01)	2013-03-11	0000-00-00	No	No	Current
51991-819-05	51991081905	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51991-819-05)	2013-03-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Propranolol Hydrochloride Extended-Release Capsules, USP	AvKARE	2026-02-24	HUMAN PRESCRIPTION DRUG LABEL	9
Propranolol Hydrochloride Extended-Release Capsules, USP	REMEDYREPACK INC.	2026-01-22	HUMAN PRESCRIPTION DRUG LABEL	14
Propranolol Hydrochloride Extended-Release Capsules, USP	Bryant Ranch Prepack	2025-10-30	HUMAN PRESCRIPTION DRUG LABEL	102
Propranolol Hydrochloride Extended-Release Capsules, USP	Bryant Ranch Prepack	2025-10-13	HUMAN PRESCRIPTION DRUG LABEL	1
Propranolol Hydrochloride Extended-Release Capsules, USP	Bryant Ranch Prepack	2025-09-10	HUMAN PRESCRIPTION DRUG LABEL	102
Propranolol Hydrochloride Extended-Release Capsules, USP	Breckenridge Pharmaceutical, Inc. \| Adare Pharmaceuticals, Inc. \| Apace Packaging LLC	2025-08-04	HUMAN PRESCRIPTION DRUG LABEL	11
Propranolol Hydrochloride Extended-Release Capsules, USP	Bryant Ranch Prepack	2024-10-04	HUMAN PRESCRIPTION DRUG LABEL	105