Labetalol HCl

Product NDC: 0185-0118
11-digit product format: 001850118
Labeler code: 0185
Product ID: 0185-0118_a4c308a8-e7f2-4f2f-b2f5-2cf74022a372
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Eon Labs, Inc.
Application: ANDA075113
Marketing category: ANDA
Marketing start: 1998-08-04
Marketing end: 2023-09-30
Substance: LABETALOL HYDROCHLORIDE
Active strength: 300 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0185-0118		D	Discontinued by firm	2026-08-17
excluded package	package	0185-0118	0185-0118-01	D	Discontinued by firm	2026-08-17
excluded package	package	0185-0118	0185-0118-05	D	Discontinued by firm	2026-08-17
excluded package	package	0185-0118	0185-0118-10	D	Discontinued by firm	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 · 48 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	0185-0118-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0185-0118-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0185-0118-05	`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	0185-0118-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0185-0118-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0185-0118-05	`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	0185-0118-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0185-0118-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0185-0118-05	`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	0185-0118-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0185-0118-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0185-0118-05	`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	0185-0118-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0185-0118-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0185-0118-05	`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	0185-0118-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0185-0118-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0185-0118-05	`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	0185-0118-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0185-0118-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0185-0118-05	`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	0185-0118-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0185-0118-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0185-0118-05	`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	0185-0118-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0185-0118-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0185-0118-05	`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	0185-0118-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0185-0118-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0185-0118-05	`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	0185-0118-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0185-0118-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0185-0118-05	`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	0185-0118-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0185-0118-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0185-0118-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075113-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1998-08-04
A075113-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-08-04
A075113-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1998-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075113-001	AB
A075113-002	AB
A075113-003	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 4 · 126 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	A075113-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1998-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075113-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075113-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1998-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075113-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1998-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075113-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075113-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1998-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075113-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1998-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075113-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075113-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1998-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075113-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1998-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075113-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075113-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1998-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075113-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1998-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075113-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075113-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1998-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075113-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1998-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075113-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075113-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1998-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075113-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1998-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075113-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075113-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1998-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075113-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1998-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075113-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075113-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1998-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075113-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1998-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075113-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075113-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1998-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075113-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1998-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075113-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075113-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1998-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075113-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1998-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075113-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075113-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1998-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075113-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1998-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075113-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075113-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1998-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075113-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1998-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075113-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	1998-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075113-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		1998-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075113-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		1998-08-04	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A075113-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075113-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075113-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075113-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075113-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075113-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075113-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075113-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075113-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075113-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075113-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075113-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075113-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075113-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075113-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075113-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075113-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075113-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075113-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075113-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075113-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075113-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075113-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075113-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075113-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075113-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075113-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075113-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075113-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075113-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075113-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075113-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075113-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075113-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075113-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075113-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075113-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075113-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075113-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075113-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0185-0118-01	EA - Each	0185-0118	fe9759a3-c801-421f-9382-72e3f7e980d6	1	2012-07-24
0185-0118-05	EA - Each	0185-0118	5b855a05-d8b4-4b93-b21a-a8be66c93e71	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LABETALOL HYDROCHLORIDE	ACTIVE INGREDIENT	1GEV3BAW9J	LABETALOL HCL TABLET, FILM COATED [EON LABS, INC.]	16
LABETALOL	ACTIVE MOIETY	R5H8897N95	LABETALOL HCL TABLET, FILM COATED [EON LABS, INC.]	16
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LABETALOL HCL TABLET, FILM COATED [EON LABS, INC.]	16
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LABETALOL HCL TABLET, FILM COATED [EON LABS, INC.]	16
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LABETALOL HCL TABLET, FILM COATED [EON LABS, INC.]	16
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LABETALOL HCL TABLET, FILM COATED [EON LABS, INC.]	16
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	LABETALOL HCL TABLET, FILM COATED [EON LABS, INC.]	16
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LABETALOL HCL TABLET, FILM COATED [EON LABS, INC.]	16
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LABETALOL HCL TABLET, FILM COATED [EON LABS, INC.]	16
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LABETALOL HCL TABLET, FILM COATED [EON LABS, INC.]	16

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1GEV3BAW9J	LABETALOL HYDROCHLORIDE	32780-64-6	LABETALOL HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0185-0118-01	00185011801	100 TABLET, FILM COATED in 1 BOTTLE (0185-0118-01)	1998-08-04	0000-00-00	No	No	Current
0185-0118-05	00185011805	500 TABLET, FILM COATED in 1 BOTTLE (0185-0118-05)	1998-08-04	0000-00-00	No	No	Current
0185-0118-10	00185011810	1000 TABLET, FILM COATED in 1 BOTTLE (0185-0118-10)	1998-08-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Labetalol Hydrochloride Tablets, USP	Bryant Ranch Prepack	2020-01-19	HUMAN PRESCRIPTION DRUG LABEL	4
Labetalol Hydrochloride Tablets, USP	Eon Labs, Inc.	2018-10-12	HUMAN PRESCRIPTION DRUG LABEL	21