Propranolol Hydrochloride

Product NDC: 0115-1693
Requested package NDC: 0115-1693-01
11-digit product format: 001151693
Labeler code: 0115
Product ID: 0115-1693_218a628d-de9d-4d32-943d-cb9cffa9515c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Propranolol Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA071976
Marketing category: ANDA
Marketing start: 1990-09-30
Marketing end: 0000-00-00
Substance: PROPRANOLOL HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	0115-1693	0115-1693-01	I	Inactivated by FDA		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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071976-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06
A071976-002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A071976-001	AB
A071976-002	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 3 · 84 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	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL			1988-04-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL			1988-04-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL			1988-04-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RS	1988-04-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071976-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL			1988-04-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071976-002	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB		1986-05-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 71 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	A071976-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A071976-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A071976-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071976-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071976-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071976-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071976-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071976-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071976-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071976-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071976-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071976-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071976-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071976-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071976-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071976-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071976-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071976-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071976-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071976-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071976-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071976-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071976-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071976-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071976-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071976-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071976-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071976-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071976-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071976-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071976-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071976-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071976-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071976-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071976-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071976-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071976-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071976-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071976-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071976-002	AB	1	`8869cabd3fbd…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0115-1693-01	2023-01-30	C162847	48780-1	f386c649-abef-0266-e053-dadaa90a7c1a	PROPRANOLOL HYDROCHLORIDE TABLETS, USP 60 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0115-1693-01	Propranolol Hydrochloride	100 in 1 BOTTLE	TABLET	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1693-01	EA - Each	0115-1693	0f370040-57e3-4357-961b-d4d889e4256c	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-1693	PROPRANOLOL HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	5	Legacy NDC, 1 package rows	20201230_d71ac16a-e2df-4630-9653-28749ece80a2.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	PROPRANOLOL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	14d0c95d-418f-40a8-bad3-e20c82424960	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071976 application number: ANDA071976
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Coupler LLC	3e50045f-abdf-3b78-e063-6394a90a4ba0	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071976 application number: ANDA071976

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
856556	propranolol HCl 60 MG Oral Tablet	PSN	d71ac16a-e2df-4630-9653-28749ece80a2	5
856556	propranolol hydrochloride 60 MG Oral Tablet	SCD	d71ac16a-e2df-4630-9653-28749ece80a2	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-1693-01	00115169301	100 TABLET in 1 BOTTLE (0115-1693-01)	100 tablet	1990-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROPRANOLOL HYDROCHLORIDE TABLETS, USP 60 mg Rx only	Amneal Pharmaceuticals of New York LLC \| Teva Czech Industries s.r.o.	2019-06-28	HUMAN PRESCRIPTION DRUG LABEL	5