Propranolol Hydrochloride

Product NDC: 0115-1661
11-digit product format: 001151661
Labeler code: 0115
Product ID: 0115-1661_6f426f6a-1366-4752-b439-da9b82db3fdb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Propranolol Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA070177
Marketing category: ANDA
Marketing start: 2016-09-19
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0115-1661		D	Discontinued by firm	2026-08-17
excluded package	package	0115-1661	0115-1661-01	D	Discontinued by firm	2026-08-17
excluded package	package	0115-1661	0115-1661-03	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0115-1661		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0115-1661	0115-1661-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0115-1661	0115-1661-03	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070177-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB		1986-05-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A070177-001	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 2 · 42 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	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070177-001	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1986-05-13	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A070177-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070177-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070177-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070177-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070177-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070177-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070177-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070177-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070177-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070177-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070177-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070177-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070177-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070177-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070177-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070177-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070177-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070177-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070177-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070177-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070177-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070177-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070177-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070177-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070177-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070177-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070177-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070177-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070177-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070177-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070177-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070177-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070177-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070177-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070177-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070177-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070177-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070177-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070177-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070177-001	AB	1	`e64feba35796…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1661-01	EA - Each	0115-1661	553d6aa6-2371-4a34-8b34-d6f59b136922	1	2016-12-07
0115-1661-03	EA - Each	0115-1661	c103941b-0d70-42b9-baf1-564779fba9f5	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-1661	PROPRANOLOL HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	7	Legacy NDC	20190614_d17f1a94-e4a7-403a-8f9c-42740751bee9.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	11873816-5789-e951-e063-6294a90ad16e	2024-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070177 application number: ANDA070177

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	5e05a9e2-289b-40d8-911a-d142ebf58882	9
856457	propranolol HCl 20 MG Oral Tablet	PSN	5e05a9e2-289b-40d8-911a-d142ebf58882	9
856519	propranolol HCl 40 MG Oral Tablet	PSN	5e05a9e2-289b-40d8-911a-d142ebf58882	9
856448	propranolol hydrochloride 10 MG Oral Tablet	SCD	5e05a9e2-289b-40d8-911a-d142ebf58882	9
856457	propranolol hydrochloride 20 MG Oral Tablet	SCD	5e05a9e2-289b-40d8-911a-d142ebf58882	9
856519	propranolol hydrochloride 40 MG Oral Tablet	SCD	5e05a9e2-289b-40d8-911a-d142ebf58882	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-1661-01	00115166101	100 TABLET in 1 BOTTLE, PLASTIC (0115-1661-01)	100 tablet	2016-09-19	0000-00-00	No	No	Current
0115-1661-03	00115166103	1000 TABLET in 1 BOTTLE, PLASTIC (0115-1661-03)	1000 tablet	2016-09-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Propranolol Hydrochloride Tablets, USP Rev. 02-2019-00 Rx Only	REMEDYREPACK INC.	2023-10-18	HUMAN PRESCRIPTION DRUG LABEL	13
Propranolol Hydrochloride Tablets, USP Rev. 02-2019-00 Rx Only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	9
Propranolol Hydrochloride Tablets, USP Rx Only	AvPAK	2022-01-18	HUMAN PRESCRIPTION DRUG LABEL	8
Propranolol Hydrochloride Tablets, USP Rev. 02-2019-00 Rx Only	NCS HealthCare of KY, LLC dba Vangard Labs	2020-12-29	HUMAN PRESCRIPTION DRUG LABEL	5
Propranolol Hydrochloride Tablets, USP Rev. 02-2019-00 Rx Only	Amneal Pharmaceuticals of New York LLC \| Teva Pharmaceuticals USA, Inc.	2019-06-12	HUMAN PRESCRIPTION DRUG LABEL	7
Propranolol Hydrochloride Tablets, USP Revised: May 2016 Rx Only	REMEDYREPACK INC.	2019-02-12	HUMAN PRESCRIPTION DRUG LABEL	3
Propranolol Hydrochloride Tablets, USP Revised: May 2016 Rx Only	NuCare Pharmaceuticals,Inc.	2018-10-03	HUMAN PRESCRIPTION DRUG LABEL	2