PROPRANOLOL HYDROCHLORIDE

Product NDC: 65841-746
11-digit product format: 658410746
Labeler code: 65841
Product ID: 65841-746_aa9c5856-379d-49b0-90b7-a16dc636d6d7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PROPRANOLOL HYDROCHLORIDE
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA090321
Marketing category: ANDA
Marketing start: 2014-04-15
Marketing end: 0000-00-00
Substance: PROPRANOLOL HYDROCHLORIDE
Active strength: 80 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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65841-746		D	Discontinued by firm	2026-10-15
excluded package	package	65841-746	65841-746-01	D	Discontinued by firm	2026-10-15
excluded package	package	65841-746	65841-746-05	D	Discontinued by firm	2026-10-15
excluded package	package	65841-746	65841-746-10	D	Discontinued by firm	2026-10-15
excluded package	package	65841-746	65841-746-16	D	Discontinued by firm	2026-10-15
excluded package	package	65841-746	65841-746-77	D	Discontinued by firm	2026-10-15

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 · 12 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	65841-746-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65841-746-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65841-746-77	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65841-746-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65841-746-05	`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	65841-746-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65841-746-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65841-746-77	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65841-746-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65841-746-05	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A090321-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25
A090321-002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25
A090321-003	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25
A090321-004	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090321-001	AB
A090321-002	AB
A090321-003	AB
A090321-004	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 · 176 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
2026-10-15 13:18:30	2026-09	A090321-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090321-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090321-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090321-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090321-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090321-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090321-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090321-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090321-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090321-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090321-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090321-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090321-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090321-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090321-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090321-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090321-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090321-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090321-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090321-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090321-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090321-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090321-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090321-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090321-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090321-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090321-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090321-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090321-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090321-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090321-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090321-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090321-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090321-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090321-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090321-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090321-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090321-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090321-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090321-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-03-25	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090321-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090321-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090321-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090321-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090321-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090321-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090321-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090321-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090321-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090321-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090321-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090321-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090321-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090321-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090321-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090321-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090321-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090321-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090321-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090321-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090321-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090321-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090321-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090321-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090321-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090321-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090321-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090321-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090321-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090321-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090321-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090321-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090321-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090321-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090321-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090321-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090321-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090321-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090321-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090321-004	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROPRANOLOL HYDROCHLORIDE	ACTIVE INGREDIENT	F8A3652H1V	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	1
PROPRANOLOL	ACTIVE MOIETY	9Y8NXQ24VQ	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [CADILA HEALTHCARE LIMITED]	1

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
65841-746-01	65841074601	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65841-746-01)		2014-04-15	0000-00-00	No	No	Current
65841-746-05	65841074605	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65841-746-05)		2014-04-15	0000-00-00	No	No	Current
65841-746-10	65841074610	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65841-746-10)		2014-04-15	0000-00-00	No	No	Current
65841-746-16	65841074616	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65841-746-16)		2014-04-15	0000-00-00	No	No	Current
65841-746-77	65841074677	100 BLISTER PACK in 1 CARTON (65841-746-77) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (65841-746-30)	100 blister pack	2014-04-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Propranolol Hydrochloride Extended-release Capsules, USP	Zydus Lifesciences Limited	2024-12-04	HUMAN PRESCRIPTION DRUG LABEL	5