Propranolol Hydrochloride

Product NDC: 68151-3727
11-digit product format: 681513727
Labeler code: 68151
Product ID: 68151-3727_2c300690-04fc-4247-b478-1695e75331ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Propranolol Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA070979
Marketing category: ANDA
Marketing start: 1987-05-15
Marketing end: 0000-00-00
Substance: PROPRANOLOL HYDROCHLORIDE
Active strength: 20 mg/5mL
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68151-3727		I	Inactivated by FDA		2026-08-17
excluded package	package	68151-3727	68151-3727-1	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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68151-3727-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68151-3727-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68151-3727-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68151-3727-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68151-3727-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68151-3727-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68151-3727-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68151-3727-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68151-3727-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68151-3727-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68151-3727-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68151-3727-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68151-3727-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68151-3727-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68151-3727-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68151-3727-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68151-3727-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68151-3727-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68151-3727-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68151-3727-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68151-3727-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68151-3727-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A070979-001	PROPRANOLOL HYDROCHLORIDE	20MG/5ML	SOLUTION / ORAL	RS	1987-05-15	`cb3db0bc1861…`

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
68151-3727-1	2020-01-31	C162847	48780-1	9d75b9d1-1ede-f424-e053-dadaa90a57ce	Propanolol Hydrochloride Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-3727-1	Propranolol Hydrochloride	1 mL in 1 SYRINGE, PLASTIC	SOLUTION	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-3727	PROPRANOLOL HYDROCHLORIDE SOLUTION [CARILION MATERIALS MANAGEMENT]	2	Legacy NDC, 1 package rows	20171229_73124cb1-3763-49b0-8317-e30705048053.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	b609cc7c-1f6a-452b-8ada-c4d2989b83dc	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070979 application number: ANDA070979
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	ATLANTIC BIOLOGICALS CORP.	40333bee-749f-0b43-e063-6394a90a149c	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070979 application number: ANDA070979
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Pharmaceutical Associates, Inc.	ec5c919b-05d1-45d2-a6e4-ac4ae1101dbb	2022-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070979 application number: ANDA070979

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
856724	propranolol HCl 20 MG in 5 mL Oral Solution	PSN	73124cb1-3763-49b0-8317-e30705048053	2
856724	propranolol hydrochloride 4 MG/ML Oral Solution	SCD	73124cb1-3763-49b0-8317-e30705048053	2
856724	propranolol hydrochloride 20 MG per 5 ML Oral Solution	SY	73124cb1-3763-49b0-8317-e30705048053	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68151-3727-1	68151372701	1 mL in 1 SYRINGE, PLASTIC	1 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Propanolol Hydrochloride Oral Solution	Carilion Materials Management	2017-12-28	HUMAN PRESCRIPTION DRUG LABEL	2