Propranolol Hydrochloride

Product NDC: 0603-5484
11-digit product format: 006035484
Labeler code: 0603
Product ID: 0603-5484_2d7e19e5-6f01-4657-a201-829ea5a74f84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: propranolol hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Endo USA, Inc.
Application: ANDA070221
Marketing category: ANDA
Marketing start: 2010-06-21
Substance: PROPRANOLOL HYDROCHLORIDE
Active strength: 40 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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A070221-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-04-14
A070221-002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1986-08-01
A070221-003	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1986-08-01
A070221-004	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-08-01
A070221-005	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A070221-001	AB
A070221-002	AB
A070221-003	AB
A070221-004	AB
A070221-005	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 6 · 210 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	A070221-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070221-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1986-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070221-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1986-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070221-004	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070221-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070221-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070221-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1986-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070221-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1986-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070221-004	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070221-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070221-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070221-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1986-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070221-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1986-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070221-004	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070221-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070221-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070221-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1986-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070221-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1986-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070221-004	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070221-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070221-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070221-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1986-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070221-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1986-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070221-004	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070221-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070221-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070221-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1986-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070221-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1986-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070221-004	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070221-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070221-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070221-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1986-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070221-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1986-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070221-004	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070221-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070221-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070221-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1986-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070221-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1986-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070221-004	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070221-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	A070221-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070221-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070221-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070221-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070221-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070221-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070221-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070221-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070221-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070221-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070221-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070221-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070221-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070221-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070221-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070221-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070221-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070221-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070221-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070221-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070221-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070221-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070221-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070221-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070221-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070221-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070221-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070221-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070221-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070221-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070221-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070221-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070221-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070221-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070221-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070221-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070221-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070221-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070221-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070221-005	AB	1	`2680178bc6a6…`

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	40 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856448	Internal RxNorm lookup
856457	Internal RxNorm lookup
856519	Internal RxNorm lookup
856556	Internal RxNorm lookup
856578	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
0d74bb04-8227-4afa-b523-ce1556150e07	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
0603-5484-21	Propranolol Hydrochloride	100 in 1 BOTTLE	TABLET	100		18
0603-5484-32	Propranolol Hydrochloride	1000 in 1 BOTTLE	TABLET	1000		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-5484-21	EA - Each	0603-5484	30ec933f-a549-4ca9-9f12-61d17a2f2e95	1	2012-07-24
0603-5484-32	EA - Each	0603-5484	a78711d7-8e3e-4f7a-9e63-5bba3fdfdd33	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 TABLET [QUALITEST PHARMACEUTICALS]	7
PROPRANOLOL	ACTIVE MOIETY	9Y8NXQ24VQ	PROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PROPRANOLOL HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]	7
PROPRANOLOL HYDROCHLORIDE	ACTIVE INGREDIENT	F8A3652H1V	PROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
PROPRANOLOL HYDROCHLORIDE	ACTIVE INGREDIENT	F8A3652H1V	PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
PROPRANOLOL	ACTIVE MOIETY	9Y8NXQ24VQ	PROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
PROPRANOLOL	ACTIVE MOIETY	9Y8NXQ24VQ	PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PROPRANOLOL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0603-5484	PROPRANOLOL HYDROCHLORIDE TABLET [ENDO USA, INC.]	18	Current NDC, Legacy NDC, 2 package rows	20240926_0d74bb04-8227-4afa-b523-ce1556150e07.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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Northwind Health Company, LLC	f2b8b894-d887-c4ee-e053-2995a90a0c0b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	29a3a271-dabc-437f-e054-00144ff8d46c	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ed10dd67-5987-4191-b2d3-9dcf40340caa	2025-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	360de855-b8be-409f-9ca6-d0a0368af174	2024-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	1c275a7b-2e85-4990-b3ad-6c675d6c2d7b	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	b27ade81-8b41-4394-aec1-d23370bfa3b7	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	16291f1b-1ce4-480a-a1fc-c20bbac4cbe7	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	fce3539f-82f3-4bb5-a6ba-c38171c67c06	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	d655fb2d-0cfd-4aad-8770-5decdcee10b2	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	062a1734-00d1-4871-8e7e-450b0ff5864c	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	6a62aad9-94e5-4ac4-8a13-9042c56d4f98	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	2b41246b-dff7-42ca-8591-d6e51e578aa8	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	905e205d-4d0b-4ce0-968e-96171164940e	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	89331052-2648-46c6-8d4c-7934ab1ee683	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	3cd58de4-9c48-46a0-a19e-11339ec33aca	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	8c681a79-bf2c-4eea-9b81-140ddba00616	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	46a32a66-6345-4230-a4f9-dc1a614380c8	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Bryant Ranch Prepack	8b3f61f9-2efc-40c1-9c80-11aa145b3484	2024-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Endo USA, Inc.	0d74bb04-8227-4afa-b523-ce1556150e07	2024-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221 ndc (product): 0603-5484
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	933f792f-341f-4d71-e053-2a95a90ad341	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070221 application number: ANDA070221

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
856519	propranolol HCl 40 MG Oral Tablet	PSN	d655fb2d-0cfd-4aad-8770-5decdcee10b2	104
856519	propranolol HCl 40 MG Oral Tablet	PSN	b27ade81-8b41-4394-aec1-d23370bfa3b7	104
856519	propranolol hydrochloride 40 MG Oral Tablet	SCD	d655fb2d-0cfd-4aad-8770-5decdcee10b2	104
856519	propranolol hydrochloride 40 MG Oral Tablet	SCD	b27ade81-8b41-4394-aec1-d23370bfa3b7	104
856519	propranolol HCl 40 MG Oral Tablet	PSN	46a32a66-6345-4230-a4f9-dc1a614380c8	101
856519	propranolol hydrochloride 40 MG Oral Tablet	SCD	46a32a66-6345-4230-a4f9-dc1a614380c8	101
856448	propranolol HCl 10 MG Oral Tablet	PSN	360de855-b8be-409f-9ca6-d0a0368af174	22
856457	propranolol HCl 20 MG Oral Tablet	PSN	360de855-b8be-409f-9ca6-d0a0368af174	22
856519	propranolol HCl 40 MG Oral Tablet	PSN	360de855-b8be-409f-9ca6-d0a0368af174	22
856519	propranolol HCl 40 MG Oral Tablet	PSN	29a3a271-dabc-437f-e054-00144ff8d46c	22
856578	propranolol HCl 80 MG Oral Tablet	PSN	360de855-b8be-409f-9ca6-d0a0368af174	22
856448	propranolol hydrochloride 10 MG Oral Tablet	SCD	360de855-b8be-409f-9ca6-d0a0368af174	22
856457	propranolol hydrochloride 20 MG Oral Tablet	SCD	360de855-b8be-409f-9ca6-d0a0368af174	22
856519	propranolol hydrochloride 40 MG Oral Tablet	SCD	29a3a271-dabc-437f-e054-00144ff8d46c	22
856519	propranolol hydrochloride 40 MG Oral Tablet	SCD	360de855-b8be-409f-9ca6-d0a0368af174	22
856578	propranolol hydrochloride 80 MG Oral Tablet	SCD	360de855-b8be-409f-9ca6-d0a0368af174	22
856448	propranolol HCl 10 MG Oral Tablet	PSN	0d74bb04-8227-4afa-b523-ce1556150e07	18
856457	propranolol HCl 20 MG Oral Tablet	PSN	0d74bb04-8227-4afa-b523-ce1556150e07	18
856519	propranolol HCl 40 MG Oral Tablet	PSN	0d74bb04-8227-4afa-b523-ce1556150e07	18
856556	propranolol HCl 60 MG Oral Tablet	PSN	0d74bb04-8227-4afa-b523-ce1556150e07	18
856578	propranolol HCl 80 MG Oral Tablet	PSN	0d74bb04-8227-4afa-b523-ce1556150e07	18
856448	propranolol hydrochloride 10 MG Oral Tablet	SCD	0d74bb04-8227-4afa-b523-ce1556150e07	18
856457	propranolol hydrochloride 20 MG Oral Tablet	SCD	0d74bb04-8227-4afa-b523-ce1556150e07	18
856519	propranolol hydrochloride 40 MG Oral Tablet	SCD	0d74bb04-8227-4afa-b523-ce1556150e07	18
856556	propranolol hydrochloride 60 MG Oral Tablet	SCD	0d74bb04-8227-4afa-b523-ce1556150e07	18
856578	propranolol hydrochloride 80 MG Oral Tablet	SCD	0d74bb04-8227-4afa-b523-ce1556150e07	18
856519	propranolol HCl 40 MG Oral Tablet	PSN	4faa7ea7-21f8-56b9-e054-00144ff8d46c	2
856519	propranolol hydrochloride 40 MG Oral Tablet	SCD	4faa7ea7-21f8-56b9-e054-00144ff8d46c	2
856457	propranolol HCl 20 MG Oral Tablet	PSN	a5daa747-26e8-4065-9e8c-fc491c45eb59	1
856519	propranolol HCl 40 MG Oral Tablet	PSN	a5daa747-26e8-4065-9e8c-fc491c45eb59	1
856519	propranolol HCl 40 MG Oral Tablet	PSN	11017c51-9fec-4a47-925a-d247f8c40f76	1
856457	propranolol hydrochloride 20 MG Oral Tablet	SCD	a5daa747-26e8-4065-9e8c-fc491c45eb59	1
856519	propranolol hydrochloride 40 MG Oral Tablet	SCD	a5daa747-26e8-4065-9e8c-fc491c45eb59	1
856519	propranolol hydrochloride 40 MG Oral Tablet	SCD	11017c51-9fec-4a47-925a-d247f8c40f76	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-5484-21	00603548421	100 TABLET in 1 BOTTLE (0603-5484-21)	100 tablet	2010-06-21	0000-00-00	No	No	Current
0603-5484-32	00603548432	1000 TABLET in 1 BOTTLE (0603-5484-32)	1000 tablet	2010-06-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Propranolol Hydrochloride Tablets, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2025-02-28	HUMAN PRESCRIPTION DRUG LABEL	22
Propranolol Hydrochloride Tablets, USP Rx only	Bryant Ranch Prepack	2024-12-09	HUMAN PRESCRIPTION DRUG LABEL	22
Propranolol Hydrochloride Tablets, USP Rx only	Bryant Ranch Prepack	2024-10-10	HUMAN PRESCRIPTION DRUG LABEL	104
Propranolol Hydrochloride Tablets, USP Rx only	Bryant Ranch Prepack	2024-10-09	HUMAN PRESCRIPTION DRUG LABEL	104
Propranolol Hydrochloride Tablets, USP Rx only	Bryant Ranch Prepack	2024-10-04	HUMAN PRESCRIPTION DRUG LABEL	101
Propranolol Hydrochloride Tablets, USP Rx only	Endo USA, Inc.	2024-09-24	HUMAN PRESCRIPTION DRUG LABEL	18
Propranolol Hydrochloride Tablets, USP Rx only	A-S Medication Solutions	2023-05-09	HUMAN PRESCRIPTION DRUG LABEL	29
Propranolol Hydrochloride Tablets, USP Rx only	REMEDYREPACK INC.	2021-08-10	HUMAN PRESCRIPTION DRUG LABEL	3
Propranolol Hydrochloride Tablets, USP Rx only	NuCare Pharmaceuticals,Inc.	2021-02-17	HUMAN PRESCRIPTION DRUG LABEL	2
PROPRANOLOL HYDROCHLORIDE TABLETS USP Rx only	NuCare Pharmaceuticals, Inc.	2020-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Propranolol Hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2020-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
Propranolol Hydrochloride Tablets, USP Rx only	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-23	HUMAN PRESCRIPTION DRUG LABEL	1
Propranolol Hydrochloride Tablets, USP Rx only	NuCare Pharmceuticals,Inc. \| NuCare Pharmaceuticals,Inc.	2017-10-31	HUMAN PRESCRIPTION DRUG LABEL	1
PROPRANOLOL HYDROCHLORIDE TABLETS USP Rx only	Aphena Pharma Solutions - Tennessee, LLC	2014-05-20	HUMAN PRESCRIPTION DRUG LABEL	1