Labetalol Hydrochloride

Product NDC: 70377-062
11-digit product format: 703770062
Labeler code: 70377
Product ID: 70377-062_f285cda1-e518-405e-9362-292ae2e14954
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Labetalol Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Biocon Pharma Inc.
Application: ANDA209603
Marketing category: ANDA
Marketing start: 2021-05-27
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: 2027-12-31
Current FDA listing: Yes

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
A209603-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20
A209603-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20
A209603-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20
A209603-004	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2024-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209603-001	AB
A209603-002	AB
A209603-003	AB
A209603-004	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 4 · 136 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	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL	AB	2024-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL		2024-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL		2024-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL		2024-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL		2024-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL		2024-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL		2024-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL		2024-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209603-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	2018-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209603-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2018-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209603-004	LABETALOL HYDROCHLORIDE	400MG	TABLET / ORAL		2024-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209603-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2018-06-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 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	A209603-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209603-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209603-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209603-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209603-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209603-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209603-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209603-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209603-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209603-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209603-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209603-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209603-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209603-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209603-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209603-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209603-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209603-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209603-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209603-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209603-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209603-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209603-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209603-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209603-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209603-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209603-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209603-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209603-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209603-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209603-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209603-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209603-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209603-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209603-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209603-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209603-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209603-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209603-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209603-003	AB	1	`301d65b070ca…`

Additional Listing Data#

Finished product: Yes
Brand name base: Labetalol Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LABETALOL HYDROCHLORIDE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1GEV3BAW9J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
896758	Internal RxNorm lookup
896762	Internal RxNorm lookup
896766	Internal RxNorm lookup
896983	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
27e4ab03-c17b-4268-912c-e45a5e8f8dd8	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70377-062-11	Labetalol Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	6
70377-062-12	Labetalol Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	6
70377-062-13	Labetalol Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70377-062-12	EA - Each	70377-062	6d53a421-9ca5-4658-b990-18b023ff02fb	1	2021-07-15
70377-062-13	EA - Each	70377-062	38828578-0366-4875-9746-5c6c41eb46d8	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70377-062	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [BIOCON PHARMA INC.]	2	Current NDC, Legacy NDC, 3 package rows	20241203_27e4ab03-c17b-4268-912c-e45a5e8f8dd8.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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	30281c4d-2fd1-167a-e063-6294a90a77c4	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	REMEDYREPACK INC.	5101b8dd-6148-465c-9bba-0209ce823fe5	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Cardinal Health 107, LLC	d3ca153c-25b2-4506-91bd-bf9d6a4c01fe	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	c0c1a162-cd30-4ac9-bc62-407493ed54a5	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Proficient Rx LP	54b75509-824b-4291-818d-71dc1b88915f	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Golden State Medical Supply, Inc.	d5ce687f-4a37-d3e6-e053-2995a90aa974	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	371cb135-6a5f-433d-a87d-ab8521c4aa6d	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	f9af85d3-a5a7-49d6-aff6-1ca2b2d75450	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	d4364caf-46c6-4144-9ba5-2c561e4f3a95	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	d207396a-068e-4229-88cc-a1a4df7aeff2	2026-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	A-S Medication Solutions	b4a5f170-a400-4986-8c64-f55d0413f0f6	2026-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Major Pharmaceuticals	35b5fd32-581d-427b-9a13-b7a02846d21d	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Biocon Pharma Inc.	27e4ab03-c17b-4268-912c-e45a5e8f8dd8	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603 ndc (product): 70377-062
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Northwind Health Company, LLC	faf7a1ff-f18a-8ca7-e053-6394a90a1b1f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Bryant Ranch Prepack	dafa7411-2857-4f5a-a587-4367cfbe2bfa	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	RedPharm Drug	1e1b7355-4802-d277-e063-6394a90aef44	2025-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	NuCare Pharmaceuticals , Inc.	3aff731f-1eec-19b5-e063-6294a90a3143	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	30280d40-28df-4c88-93bd-357a7c528906	2024-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209603 application number: ANDA209603

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
896758	labetalol HCl 100 MG Oral Tablet	PSN	27e4ab03-c17b-4268-912c-e45a5e8f8dd8	6
896758	labetalol HCl 100 MG Oral Tablet	PSN	35b5fd32-581d-427b-9a13-b7a02846d21d	6
896762	labetalol HCl 200 MG Oral Tablet	PSN	27e4ab03-c17b-4268-912c-e45a5e8f8dd8	6
896762	labetalol HCl 200 MG Oral Tablet	PSN	35b5fd32-581d-427b-9a13-b7a02846d21d	6
896766	labetalol HCl 300 MG Oral Tablet	PSN	27e4ab03-c17b-4268-912c-e45a5e8f8dd8	6
896766	labetalol HCl 300 MG Oral Tablet	PSN	35b5fd32-581d-427b-9a13-b7a02846d21d	6
896983	labetalol HCl 400 MG Oral Tablet	PSN	27e4ab03-c17b-4268-912c-e45a5e8f8dd8	6
896758	labetalol hydrochloride 100 MG Oral Tablet	SCD	27e4ab03-c17b-4268-912c-e45a5e8f8dd8	6
896758	labetalol hydrochloride 100 MG Oral Tablet	SCD	35b5fd32-581d-427b-9a13-b7a02846d21d	6
896762	labetalol hydrochloride 200 MG Oral Tablet	SCD	27e4ab03-c17b-4268-912c-e45a5e8f8dd8	6
896762	labetalol hydrochloride 200 MG Oral Tablet	SCD	35b5fd32-581d-427b-9a13-b7a02846d21d	6
896766	labetalol hydrochloride 300 MG Oral Tablet	SCD	27e4ab03-c17b-4268-912c-e45a5e8f8dd8	6
896766	labetalol hydrochloride 300 MG Oral Tablet	SCD	35b5fd32-581d-427b-9a13-b7a02846d21d	6
896983	labetalol hydrochloride 400 MG Oral Tablet	SCD	27e4ab03-c17b-4268-912c-e45a5e8f8dd8	6
896758	labetalol HCl 100 MG Oral Tablet	PSN	d5ce687f-4a37-d3e6-e053-2995a90aa974	4
896762	labetalol HCl 200 MG Oral Tablet	PSN	d5ce687f-4a37-d3e6-e053-2995a90aa974	4
896766	labetalol HCl 300 MG Oral Tablet	PSN	d5ce687f-4a37-d3e6-e053-2995a90aa974	4
896758	labetalol hydrochloride 100 MG Oral Tablet	SCD	d5ce687f-4a37-d3e6-e053-2995a90aa974	4
896762	labetalol hydrochloride 200 MG Oral Tablet	SCD	d5ce687f-4a37-d3e6-e053-2995a90aa974	4
896766	labetalol hydrochloride 300 MG Oral Tablet	SCD	d5ce687f-4a37-d3e6-e053-2995a90aa974	4
896766	labetalol HCl 300 MG Oral Tablet	PSN	d4364caf-46c6-4144-9ba5-2c561e4f3a95	3
896766	labetalol hydrochloride 300 MG Oral Tablet	SCD	d4364caf-46c6-4144-9ba5-2c561e4f3a95	3
896766	labetalol HCl 300 MG Oral Tablet	PSN	dafa7411-2857-4f5a-a587-4367cfbe2bfa	2
896766	labetalol HCl 300 MG Oral Tablet	PSN	1e1b7355-4802-d277-e063-6394a90aef44	2
896766	labetalol hydrochloride 300 MG Oral Tablet	SCD	dafa7411-2857-4f5a-a587-4367cfbe2bfa	2
896766	labetalol hydrochloride 300 MG Oral Tablet	SCD	1e1b7355-4802-d277-e063-6394a90aef44	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70377-062-11	70377006211	30 TABLET, FILM COATED in 1 BOTTLE (70377-062-11)	2021-05-27	0000-00-00	No	No	Current
70377-062-12	70377006212	100 TABLET, FILM COATED in 1 BOTTLE (70377-062-12)	2021-05-27	0000-00-00	No	No	Current
70377-062-13	70377006213	500 TABLET, FILM COATED in 1 BOTTLE (70377-062-13)	2021-05-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LABETALOL HYDROCHLORIDE TABLETS USP Rx only	Golden State Medical Supply, Inc.	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL	4
LABETALOL HYDROCHLORIDE TABLETS USP Rx only	A-S Medication Solutions	2026-03-26	Human Prescription Drug Label	3
LABETALOL HYDROCHLORIDE TABLETS USP Rx only	Major Pharmaceuticals	2026-03-03	HUMAN PRESCRIPTION DRUG LABEL	6
LABETALOL HYDROCHLORIDE TABLETS USP Rx only	Biocon Pharma Inc. \| Appco Pharma LLC \| Piramal Pharma Limited	2026-02-19	Human Prescription Drug Label	6
LABETALOL HYDROCHLORIDE TABLETS USP Rx only	Bryant Ranch Prepack	2025-10-23	HUMAN PRESCRIPTION DRUG LABEL	2
LABETALOL HYDROCHLORIDE TABLETS USP Rx only	RedPharm Drug	2025-07-29	HUMAN PRESCRIPTION DRUG LABEL	2
LABETALOL HYDROCHLORIDE TABLETS USP Rx only	Bryant Ranch Prepack	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL	102
LABETALOL HYDROCHLORIDE TABLETS USP Rx only	Bryant Ranch Prepack	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL	102