Propranolol Hydrochloride

Product NDC: 42689-013
11-digit product format: 426890013
Labeler code: 42689
Product ID: 42689-013_81548a65-4cc7-4e02-9846-590737a74469
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Propranolol Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Nortec Development Associates, Inc
Application: ANDA078065
Marketing category: ANDA
Marketing start: 2015-05-01
Marketing end: 0000-00-00
Substance: PROPRANOLOL HYDROCHLORIDE
Active strength: 120 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	42689-013		I	Inactivated by FDA	2026-08-17
excluded package	package	42689-013	42689-013-01	I	Inactivated by FDA	2026-08-17
excluded package	package	42689-013	42689-013-10	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 · 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
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42689-013-10	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42689-013-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42689-013-10	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42689-013-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42689-013-10	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42689-013-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42689-013-10	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42689-013-01	`8dfbde2a14a4…`	`c9ff85d89658…`

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

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
A078065-001	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26
A078065-002	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26
A078065-003	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26
A078065-004	PROPRANOLOL HYDROCHLORIDE	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078065-001	AB
A078065-002	AB
A078065-003	AB
A078065-004	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 · 168 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	A078065-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078065-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078065-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078065-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078065-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078065-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078065-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078065-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078065-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078065-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078065-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078065-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078065-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078065-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078065-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078065-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078065-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078065-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078065-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078065-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078065-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078065-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078065-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078065-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078065-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078065-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078065-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078065-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078065-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078065-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078065-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078065-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078065-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078065-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078065-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078065-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078065-001	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078065-002	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078065-003	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078065-004	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2007-01-26	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A078065-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078065-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078065-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078065-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078065-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078065-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078065-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078065-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078065-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078065-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078065-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078065-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078065-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078065-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078065-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078065-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078065-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078065-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078065-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078065-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078065-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078065-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078065-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078065-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078065-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078065-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078065-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078065-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078065-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078065-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078065-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078065-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078065-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078065-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078065-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078065-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078065-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078065-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078065-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078065-004	AB	1	`d8e5a09893c0…`

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, Related label table
NDC	Effective	Related label
42689-013-01	2026-01-29	Rx Only
42689-013-10	2026-01-29	Rx Only
42689-013-01	2022-12-21	Rx Only
42689-013-10	2022-12-21	Rx Only
42689-013-01	2021-01-29	Rx Only
42689-013-10	2021-01-29	Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42689-013-01	Propranolol Hydrochloride	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		5
42689-013-10	Propranolol Hydrochloride	1000 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1000		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Propranolol Hydrochloride	ACTIVE INGREDIENT	F8A3652H1V	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]	1
PROPRANOLOL	ACTIVE MOIETY	9Y8NXQ24VQ	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]	1
ETHYLCELLULOSE (45 MPA.S)	INACTIVE INGREDIENT	V7AD894FAZ	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42689-013	PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTEC DEVELOPMENT ASSOCIATES, INC]	5	Legacy NDC, 2 package rows	20241204_b756f602-62c9-41ef-a934-834ac81b46ae.zip

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
856460	propranolol HCl 120 MG 24HR Extended Release Oral Capsule	PSN	b756f602-62c9-41ef-a934-834ac81b46ae	5
856481	propranolol HCl 160 MG 24HR Extended Release Oral Capsule	PSN	b756f602-62c9-41ef-a934-834ac81b46ae	5
856535	propranolol HCl 60 MG 24HR Extended Release Oral Capsule	PSN	b756f602-62c9-41ef-a934-834ac81b46ae	5
856569	propranolol HCl 80 MG 24HR Extended Release Oral Capsule	PSN	b756f602-62c9-41ef-a934-834ac81b46ae	5
856460	24 HR propranolol hydrochloride 120 MG Extended Release Oral Capsule	SCD	b756f602-62c9-41ef-a934-834ac81b46ae	5
856481	24 HR propranolol hydrochloride 160 MG Extended Release Oral Capsule	SCD	b756f602-62c9-41ef-a934-834ac81b46ae	5
856535	24 HR propranolol hydrochloride 60 MG Extended Release Oral Capsule	SCD	b756f602-62c9-41ef-a934-834ac81b46ae	5
856569	24 HR propranolol hydrochloride 80 MG Extended Release Oral Capsule	SCD	b756f602-62c9-41ef-a934-834ac81b46ae	5
856460	propranolol hydrochloride 120 MG 24 HR Extended Release Oral Capsule	SY	b756f602-62c9-41ef-a934-834ac81b46ae	5
856481	propranolol hydrochloride 160 MG 24 HR Extended Release Oral Capsule	SY	b756f602-62c9-41ef-a934-834ac81b46ae	5
856535	propranolol hydrochloride 60 MG 24 HR Extended Release Oral Capsule	SY	b756f602-62c9-41ef-a934-834ac81b46ae	5
856569	propranolol hydrochloride 80 MG 24 HR Extended Release Oral Capsule	SY	b756f602-62c9-41ef-a934-834ac81b46ae	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42689-013-01	42689001301	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-013-01)	2015-05-01	0000-00-00	No	No	Current
42689-013-10	42689001310	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42689-013-10)	2015-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rx Only	Nortec Development Associates, Inc \| Glatt Air Techniques, Inc.	2024-11-22	HUMAN PRESCRIPTION DRUG LABEL	5