Propranolol Hydrochloride

Product NDC: 70934-922
11-digit product format: 709340922
Labeler code: 70934
Product ID: 70934-922_dc661c83-f91e-351a-e053-2a95a90a6e8a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Propranolol Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA070322
Marketing category: ANDA
Marketing start: 2021-11-12
Marketing end: 0000-00-00
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: 2023-12-31
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	70934-922		D	Discontinued by firm	2026-10-12
excluded package	package	70934-922	70934-922-30	D	Discontinued by firm	2026-10-12
excluded package	package	70934-922	70934-922-90	D	Discontinued by firm	2026-10-12

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-922-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-922-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-922-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-922-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-922-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-922-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-922-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-922-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-922-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-922-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-922-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-922-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70934-922-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70934-922-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70934-922-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70934-922-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70934-922-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70934-922-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70934-922-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70934-922-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70934-922-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70934-922-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70934-922-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70934-922-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A070322-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-08-04
A070322-002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-10-22
A070322-003	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-10-22
A070322-004	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-10-22
A070322-005	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A070322-001	AB
A070322-002	AB
A070322-003	AB
A070322-004	AB
A070322-005	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 6 · 215 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
2026-09-14 22:38:34	2026-08	A070322-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-08-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070322-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070322-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070322-004	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-10-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070322-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070322-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070322-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070322-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070322-004	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-10-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070322-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070322-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070322-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070322-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070322-004	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070322-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070322-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070322-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070322-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070322-004	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070322-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070322-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070322-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070322-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070322-004	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070322-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070322-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070322-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070322-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070322-004	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070322-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070322-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070322-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070322-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070322-004	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070322-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070322-001	PROPRANOLOL HYDROCHLORIDE	80MG	TABLET / ORAL	AB	1986-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070322-002	PROPRANOLOL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1985-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070322-003	PROPRANOLOL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	1985-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070322-004	PROPRANOLOL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	1985-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070322-005	PROPRANOLOL HYDROCHLORIDE	60MG	TABLET / ORAL	AB	1986-09-24	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A070322-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070322-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070322-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070322-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070322-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070322-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070322-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070322-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070322-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070322-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070322-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070322-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070322-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070322-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070322-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070322-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070322-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070322-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070322-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070322-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070322-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070322-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070322-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070322-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070322-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070322-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070322-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070322-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070322-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070322-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070322-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070322-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070322-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070322-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070322-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070322-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070322-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070322-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070322-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070322-005	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

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

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 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Propranolol Hydrochloride	PROPRANOLOL HYDROCHLORIDE	Proficient Rx LP	ea86beb4-33c8-4841-a742-82212ce716d2	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070322 application number: ANDA070322

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F8A3652H1V	PROPRANOLOL HYDROCHLORIDE	318-98-9	PROPRANOLOL HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-922-30	70934092230	30 TABLET in 1 BOTTLE, PLASTIC (70934-922-30)	30 tablet	2022-04-11	0000-00-00	No	No	Current
70934-922-90	70934092290	90 TABLET in 1 BOTTLE, PLASTIC (70934-922-90)	90 tablet	2021-11-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROPRANOLOL HYDROCHLORIDE TABLETS, USPRx	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-13	HUMAN PRESCRIPTION DRUG LABEL	3