Propranolol Hydrochloride

Product NDC: 0904-7467
11-digit product format: 009047467
Labeler code: 0904
Product ID: 0904-7467_eba5a266-7acd-4a0b-b1ce-61c313bae40e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Propranolol Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA071972
Marketing category: ANDA
Marketing start: 2025-11-21
Substance: PROPRANOLOL HYDROCHLORIDE
Active strength: 10 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 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A071972-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06
A071972-002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06
A071972-003	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A071972-001	AB
A071972-002	AB
A071972-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071972-002	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1988-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071972-003	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1988-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071972-001	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1988-04-06	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A071972-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A071972-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A071972-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A071972-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071972-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A071972-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A071972-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071972-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071972-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071972-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071972-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071972-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071972-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071972-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071972-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071972-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071972-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071972-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071972-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071972-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071972-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071972-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071972-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071972-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071972-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071972-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071972-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071972-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071972-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071972-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071972-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071972-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071972-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071972-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071972-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071972-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071972-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071972-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071972-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071972-001	AB	1	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	10 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856448	Internal RxNorm lookup
856457	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
e7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba	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
0904-7467-61	Propranolol Hydrochloride	1 in 1 BLISTER PACK	TABLET	1		3
0904-7467-61	Propranolol Hydrochloride	100 in 1 CARTON	TABLET	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7467-61	EA - Each	0904-7467	014ff223-710c-42a8-a444-7086ed82c8bb	1	2026-03-17

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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	013a485a-4227-46ae-b19f-c550302fcb96	2024-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071972 application number: ANDA071972
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	4d24ea79-ba56-44f4-b1a6-e27235176c4a	2024-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071972 application number: ANDA071972
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	A-S Medication Solutions	7b751df5-0751-435b-8755-3d50476cabd2	2024-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071972 application number: ANDA071972
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	A-S Medication Solutions	325dda2c-ecd9-4368-8779-7ff505b2b138	2024-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071972 application number: ANDA071972
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	A-S Medication Solutions	d1110a10-a7f4-4295-9e94-8fbb56f77f67	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071972 application number: ANDA071972

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
856448	propranolol HCl 10 MG Oral Tablet	PSN	e7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba	3
856457	propranolol HCl 20 MG Oral Tablet	PSN	e7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba	3
856448	propranolol hydrochloride 10 MG Oral Tablet	SCD	e7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba	3
856457	propranolol hydrochloride 20 MG Oral Tablet	SCD	e7218c9b-b9b8-4cf0-a2c7-c759ad3a65ba	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0904-7467-61	00904746761	100 BLISTER PACK in 1 CARTON (0904-7467-61) / 1 TABLET in 1 BLISTER PACK	100 blister pack	2025-11-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Propranolol Hydrochloride Tablets, USP (10 mg, 20 mg, 40 mg, 60 mg and 80 mg) Rx only	Major Pharmaceuticals	2026-07-14	HUMAN PRESCRIPTION DRUG LABEL	4