Propranolol Hydrochloride

Product NDC: 10544-286
11-digit product format: 105440286
Labeler code: 10544
Product ID: 10544-286_1350786d-28a6-3b80-e054-00144ff8d46c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: propranolol hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Blenheim Pharmacal, Inc.
Application: NDA018553
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2013-11-18
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: E
Listing certified through: 2017-12-31
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	10544-286		I	Inactivated by FDA		2026-08-17
excluded package	package	10544-286	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	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	10544-286-30	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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	RLD / RS	Approval date
N018553-001	INDERAL LA	PROPRANOLOL HYDROCHLORIDE	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19
N018553-002	INDERAL LA	PROPRANOLOL HYDROCHLORIDE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19
N018553-003	INDERAL LA	PROPRANOLOL HYDROCHLORIDE	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19
N018553-004	INDERAL LA	PROPRANOLOL HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018553-001	AB
N018553-002	AB
N018553-003	AB
N018553-004	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018553-001	INDERAL LA	160MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1983-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018553-002	INDERAL LA	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018553-003	INDERAL LA	120MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1983-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018553-004	INDERAL LA	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1987-03-18	`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	N018553-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018553-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018553-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018553-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018553-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018553-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018553-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018553-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018553-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018553-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018553-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018553-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018553-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018553-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018553-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018553-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018553-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018553-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018553-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018553-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018553-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018553-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018553-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018553-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018553-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018553-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018553-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018553-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018553-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018553-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018553-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018553-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018553-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018553-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018553-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018553-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018553-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018553-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018553-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018553-004	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10544-286-30	2020-01-31	C162847	48780-1	9d75b9d0-4558-f424-e053-dadaa90a57ce	Propranolol hydrochloride extended-release capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10544-286-30	Propranolol HydrochlorideER	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10544-286-30	EA - Each	10544-286	46dbee84-99a3-4a2a-b8cd-df6265ec2a81	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROPRANOLOL HYDROCHLORIDE	ACTIVE INGREDIENT	F8A3652H1V	PROPRANOLOL HYDROCHLORIDE ER (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	3
PROPRANOLOL	ACTIVE MOIETY	9Y8NXQ24VQ	PROPRANOLOL HYDROCHLORIDE ER (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROPRANOLOL HYDROCHLORIDE ER (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	3
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	PROPRANOLOL HYDROCHLORIDE ER (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	3
ETHYLCELLULOSE (100 MPA.S)	INACTIVE INGREDIENT	47MLB0F1MV	PROPRANOLOL HYDROCHLORIDE ER (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PROPRANOLOL HYDROCHLORIDE ER (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PROPRANOLOL HYDROCHLORIDE ER (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	3
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	PROPRANOLOL HYDROCHLORIDE ER (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROPRANOLOL HYDROCHLORIDE ER (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10544-286	PROPRANOLOL HYDROCHLORIDE ER (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [BLENHEIM PHARMACAL, INC.]	3	Legacy NDC, 1 package rows	20150410_0fc60597-a43b-1a0f-e054-00144ff88e88.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 ER	PROPRANOLOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	5415904b-90da-48e8-9f9e-f86749aa129c	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018553 application number: NDA018553
INDERAL LA	PROPRANOLOL HYDROCHLORIDE	ANI Pharmaceuticals, Inc.	35d28979-36b1-4630-b85e-a44e0a443734	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018553 application number: NDA018553

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
856569	propranolol HCl 80 MG 24HR Extended Release Oral Capsule	PSN	0fc60597-a43b-1a0f-e054-00144ff88e88	3
856569	24 HR propranolol hydrochloride 80 MG Extended Release Oral Capsule	SCD	0fc60597-a43b-1a0f-e054-00144ff88e88	3
856569	propranolol hydrochloride 80 MG 24 HR Extended Release Oral Capsule	SY	0fc60597-a43b-1a0f-e054-00144ff88e88	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10544-286-30	10544028630	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Propranolol hydrochloride extended-release capsules	Blenheim Pharmacal, Inc.	2015-04-09	HUMAN PRESCRIPTION DRUG LABEL	3