Labetalol Hydrochloride

Product NDC: 10135-711
11-digit product format: 101350711
Labeler code: 10135
Product ID: 10135-711_23e98950-6176-fa93-e063-6294a90a60a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA075215
Marketing category: ANDA
Marketing start: 2020-10-01
Substance: LABETALOL
Active strength: 100 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 9 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	10135-711-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10135-711-05	`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	10135-711-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10135-711-05	`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	10135-711-01	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10135-711-05	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A075215-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29
A075215-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29
A075215-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075215-001	AB
A075215-002	AB
A075215-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075215-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	1999-07-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075215-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	1999-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075215-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1999-07-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075215-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075215-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075215-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075215-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075215-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075215-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075215-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075215-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075215-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075215-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075215-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075215-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075215-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075215-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075215-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075215-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075215-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075215-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075215-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075215-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075215-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075215-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075215-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075215-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075215-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075215-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075215-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075215-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075215-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075215-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075215-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075215-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075215-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075215-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075215-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075215-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075215-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075215-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075215-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075215-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Labetalol Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LABETALOL	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R5H8897N95	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
896758	Internal RxNorm lookup
896762	Internal RxNorm lookup
896766	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
28c91727-e5a8-48b3-a4df-d7bec8feda40	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
baf61d8c-dcd3-e95d-db84-9bb0d0a2b77f	Product name	2	20220311
759f1c41-9262-4238-8cee-33988631aaf4	Product name	5	20220217
3b2edbb4-6acf-4674-b1d9-22addd3dad21	Product name	1	20210527

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
10135-711-01	2022-08-30	Labetalol Hydrochloride Tablets
10135-711-05	2022-08-30	Labetalol Hydrochloride Tablets
10135-711-01	2022-01-28	Labetalol Hydrochloride Tablets
10135-711-05	2022-01-28	Labetalol Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-711-01	Labetalol Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		5
10135-711-05	Labetalol Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-711-01	EA - Each	10135-711	6d133128-10eb-4c27-bd6e-6199de2ec781	1	2022-10-06
10135-711-05	EA - Each	10135-711	0625296b-836d-41c9-a2cc-07792f2586ac	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-711	LABETALOL HYDROCHLORIDE (LABETALOL) TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	5	Current NDC, Legacy NDC, 2 package rows	20241009_28c91727-e5a8-48b3-a4df-d7bec8feda40.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	3909ac9e-6818-4c5d-ad0e-52865a574b45	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	35e7bce0-d9ff-4f8b-95c5-218da2a2d929	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	f7f7fade-98a6-4741-bfb9-f1eb54ad4565	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	0db22a64-1863-4188-850b-273ea746e327	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	d8b69cc9-bdee-4e24-a3d8-d1887de5a17d	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	6f919513-500e-4a05-935e-b6fc1615368a	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Innogenix, Inc.	82fc2d64-0572-4a9b-94fc-f6eb8d930c54	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Method Pharmaceuticals, LLC	733d6e32-ac90-4796-bf25-9d5887c897a5	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	0dcd514d-bda8-484b-8cf1-f5656aaab9ce	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	20c26652-52da-4eef-8486-f91eb30e9ff7	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	REMEDYREPACK INC.	e2e50571-d8c1-43e7-b90f-877ba1c35c9b	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	5faacbcc-f88f-42f7-8702-791ee82c4d18	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	64cd636d-8b48-4f29-b41d-4a048335793e	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL	Marlex Pharmaceuticals Inc	28c91727-e5a8-48b3-a4df-d7bec8feda40	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215 ndc (product): 10135-711
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	94abdd54-a8e2-4858-8183-6c5d04dbceb5	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	1fce27dd-90a6-45cf-9bd7-13147d3cc0d7	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	706a877b-c388-43e7-b083-518111b288b0	2024-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	5a39bb96-4a60-49e8-859c-16bda0fe18e4	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	143ae21e-c350-4c92-b318-7537f4e46596	2024-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075215 application number: ANDA075215

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R5H8897N95	LABETALOL	36894-69-6	LABETALOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
896758	labetalol HCl 100 MG Oral Tablet	PSN	28c91727-e5a8-48b3-a4df-d7bec8feda40	5
896762	labetalol HCl 200 MG Oral Tablet	PSN	28c91727-e5a8-48b3-a4df-d7bec8feda40	5
896766	labetalol HCl 300 MG Oral Tablet	PSN	28c91727-e5a8-48b3-a4df-d7bec8feda40	5
896758	labetalol hydrochloride 100 MG Oral Tablet	SCD	28c91727-e5a8-48b3-a4df-d7bec8feda40	5
896762	labetalol hydrochloride 200 MG Oral Tablet	SCD	28c91727-e5a8-48b3-a4df-d7bec8feda40	5
896766	labetalol hydrochloride 300 MG Oral Tablet	SCD	28c91727-e5a8-48b3-a4df-d7bec8feda40	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
10135-711-01	10135071101	100 TABLET, FILM COATED in 1 BOTTLE (10135-711-01)	2020-10-01	0000-00-00	No	No	Current
10135-711-05	10135071105	500 TABLET, FILM COATED in 1 BOTTLE (10135-711-05)	2020-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Labetalol Hydrochloride Tablets	Marlex Pharmaceuticals Inc	2024-10-07	HUMAN PRESCRIPTION DRUG LABEL	5