Propranolol Hydrochloride

Product NDC: 62559-533
11-digit product format: 625590533
Labeler code: 62559
Product ID: 62559-533_200aecd3-b441-4856-a9fc-6841ada5489c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: propranolol hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: NDA018553
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2017-12-21
Substance: PROPRANOLOL HYDROCHLORIDE
Active strength: 160 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	RLD / RS	Approval date
N018553-001	INDERAL LA	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19
N018553-002	INDERAL LA	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19
N018553-003	INDERAL LA	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19
N018553-004	INDERAL LA	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018553-001	AB
N018553-002	AB
N018553-003	AB
N018553-004	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`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	N018553-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018553-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018553-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018553-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018553-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018553-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018553-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018553-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018553-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018553-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018553-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018553-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018553-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018553-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018553-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018553-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018553-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018553-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018553-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018553-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018553-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018553-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018553-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018553-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018553-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018553-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018553-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018553-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018553-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018553-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018553-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018553-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018553-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018553-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018553-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018553-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018553-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018553-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018553-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018553-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Propranolol Hydrochloride
Brand name suffix: ER
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROPRANOLOL HYDROCHLORIDE	160 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
5415904b-90da-48e8-9f9e-f86749aa129c	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
62559-533-01	Propranolol HydrochlorideER	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62559-533-01	EA - Each	62559-533	efd2b74b-c678-4cd2-81a3-cd290634678f	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62559-533	PROPRANOLOL HYDROCHLORIDE ER (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]	9	Current NDC, Legacy NDC, 1 package rows	20240802_5415904b-90da-48e8-9f9e-f86749aa129c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propranolol Hydrochloride ER	PROPRANOLOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	5415904b-90da-48e8-9f9e-f86749aa129c	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018553 application number: NDA018553 ndc (product): 62559-533
INDERAL LA	PROPRANOLOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	35d28979-36b1-4630-b85e-a44e0a443734	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018553 application number: NDA018553

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	5415904b-90da-48e8-9f9e-f86749aa129c	9
856481	propranolol HCl 160 MG 24HR Extended Release Oral Capsule	PSN	5415904b-90da-48e8-9f9e-f86749aa129c	9
856535	propranolol HCl 60 MG 24HR Extended Release Oral Capsule	PSN	5415904b-90da-48e8-9f9e-f86749aa129c	9
856569	propranolol HCl 80 MG 24HR Extended Release Oral Capsule	PSN	5415904b-90da-48e8-9f9e-f86749aa129c	9
856460	24 HR propranolol hydrochloride 120 MG Extended Release Oral Capsule	SCD	5415904b-90da-48e8-9f9e-f86749aa129c	9
856481	24 HR propranolol hydrochloride 160 MG Extended Release Oral Capsule	SCD	5415904b-90da-48e8-9f9e-f86749aa129c	9
856535	24 HR propranolol hydrochloride 60 MG Extended Release Oral Capsule	SCD	5415904b-90da-48e8-9f9e-f86749aa129c	9
856569	24 HR propranolol hydrochloride 80 MG Extended Release Oral Capsule	SCD	5415904b-90da-48e8-9f9e-f86749aa129c	9
856460	propranolol hydrochloride 120 MG 24 HR Extended Release Oral Capsule	SY	5415904b-90da-48e8-9f9e-f86749aa129c	9
856481	propranolol hydrochloride 160 MG 24 HR Extended Release Oral Capsule	SY	5415904b-90da-48e8-9f9e-f86749aa129c	9
856535	propranolol hydrochloride 60 MG 24 HR Extended Release Oral Capsule	SY	5415904b-90da-48e8-9f9e-f86749aa129c	9
856569	propranolol hydrochloride 80 MG 24 HR Extended Release Oral Capsule	SY	5415904b-90da-48e8-9f9e-f86749aa129c	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62559-533-01	62559053301	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-533-01)	2017-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Propranolol Hydrochloride Extended-Release Capsules USP	ANI Pharmaceuticals, Inc.	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	9