Propranolol Hydrochloride

Product NDC: 43353-084
Requested package NDC: 43353-084-60
11-digit product format: 433530084
Labeler code: 43353
Product ID: 43353-084_39e1f574-b4d0-461a-9845-16f1ded3854a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: propranolol hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA070213
Marketing category: ANDA
Marketing start: 1985-11-19
Marketing end: 0000-00-00
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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	43353-084	43353-084-60	D	Discontinued by firm		2026-08-17

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
A070213-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-11-19
A070213-002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-11-19
A070213-003	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-11-19
A070213-004	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1985-11-19
A070213-005	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2011-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070213-001	AB
A070213-002	AB
A070213-003	AB
A070213-004	AB
A070213-005	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	A070213-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070213-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070213-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070213-004	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1985-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070213-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2011-04-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070213-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070213-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070213-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070213-004	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1985-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070213-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2011-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070213-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070213-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070213-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070213-004	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1985-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070213-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2011-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070213-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070213-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070213-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070213-004	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1985-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070213-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2011-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070213-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070213-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070213-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070213-004	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1985-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070213-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2011-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070213-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070213-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070213-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070213-004	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1985-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070213-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2011-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070213-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070213-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070213-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070213-004	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1985-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070213-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2011-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070213-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070213-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070213-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070213-004	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1985-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070213-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	2011-04-08	`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	A070213-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070213-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070213-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070213-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070213-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070213-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070213-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070213-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070213-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070213-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070213-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070213-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070213-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070213-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070213-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070213-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070213-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070213-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070213-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070213-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070213-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070213-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070213-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070213-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070213-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070213-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070213-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070213-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070213-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070213-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070213-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070213-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070213-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070213-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070213-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070213-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070213-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070213-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070213-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070213-005	AB	1	`2680178bc6a6…`

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
43353-084-60	Propranolol Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-084-60	EA - Each	43353-084	b6465e0d-6f96-481a-a981-9a554c1d2341	1	2016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-084	PROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 1 package rows	20160713_7da9bb37-cc22-4eff-8de0-429f64cb599e.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	Golden State Medical Supply, Inc.	8cbac6dc-ef1d-6662-e053-2995a90af13f	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070213 application number: ANDA070213
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	7da9bb37-cc22-4eff-8de0-429f64cb599e	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070213 application number: ANDA070213 ndc (package): 43353-084-60 ndc (product): 43353-084 ndc11 (package): 43353008460
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	b94dcec7-7633-4a33-9cea-48161adeaf93	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070213 application number: ANDA070213
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	3c05ab1f-05b0-494a-b640-667e7cf517a1	2021-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070213 application number: ANDA070213

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
856457	propranolol HCl 20 MG Oral Tablet	PSN	7da9bb37-cc22-4eff-8de0-429f64cb599e	2
856519	propranolol HCl 40 MG Oral Tablet	PSN	7da9bb37-cc22-4eff-8de0-429f64cb599e	2
856457	propranolol hydrochloride 20 MG Oral Tablet	SCD	7da9bb37-cc22-4eff-8de0-429f64cb599e	2
856519	propranolol hydrochloride 40 MG Oral Tablet	SCD	7da9bb37-cc22-4eff-8de0-429f64cb599e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-084-60	43353008460	90 TABLET in 1 BOTTLE, PLASTIC (43353-084-60)	90 tablet	2015-07-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Propranolol Hydrochloride - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2026-01-22	HUMAN PRESCRIPTION DRUG LABEL	2