Labetalol Hydrochloride Tablets, USP Rx only

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-30
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 21:18:36

Label at a glance#

ProductLabetalol Hydrochloride

Active ingredientLABETALOL HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1163-3

Labetalol hydrochloride tablets, 100 mg

Rx only

30 tablets

NDC 70771-1164-3

Labetalol hydrochloride tablets, 200 mg

Rx only

30 tablets

NDC 70771-1165-3

Labetalol hydrochloride tablets, 300 mg

Rx only

30 tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
896758	labetalol HCl 100 MG Oral Tablet	PSN	6
896762	labetalol HCl 200 MG Oral Tablet	PSN	6
896766	labetalol HCl 300 MG Oral Tablet	PSN	6
896758	labetalol hydrochloride 100 MG Oral Tablet	SCD	6
896762	labetalol hydrochloride 200 MG Oral Tablet	SCD	6
896766	labetalol hydrochloride 300 MG Oral Tablet	SCD	6

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LABETALOL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
70771-1163-1	Labetalol Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	6
70771-1163-3	Labetalol Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	6
70771-1163-5	Labetalol Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	6
70771-1163-9	Labetalol Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	6
70771-1164-1	Labetalol Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	6
70771-1164-3	Labetalol Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	6
70771-1164-5	Labetalol Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	6
70771-1164-9	Labetalol Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	6
70771-1165-1	Labetalol Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	6
70771-1165-3	Labetalol Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	6
70771-1165-5	Labetalol Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	6
70771-1165-9	Labetalol Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1163	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 4 package rows	20241204_a3c0cc1e-1c01-4009-afdc-d35a66546aec.zip
70771-1164	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 4 package rows	20241204_a3c0cc1e-1c01-4009-afdc-d35a66546aec.zip
70771-1165	LABETALOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 4 package rows	20241204_a3c0cc1e-1c01-4009-afdc-d35a66546aec.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

Labetalol Hydrochloride
LABETALOL
ALUMINUM OXIDE
D&C YELLOW NO. 10
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TITANIUM DIOXIDE
FD&C BLUE NO. 1--ALUMINUM LAKE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1163	70771-1163-3, 70771-1163-9, 70771-1163-1, 70771-1163-5
70771-1164	70771-1164-3, 70771-1164-9, 70771-1164-1, 70771-1164-5
70771-1165	70771-1165-3, 70771-1165-9, 70771-1165-1, 70771-1165-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LABETALOL HYDROCHLORIDE	1GEV3BAW9J	ACTIB
ALUMINUM OXIDE	LMI26O6933	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
LABETALOL HYDROCHLORIDE	1GEV3BAW9J	ACTIB
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STARCH, CORN	O8232NY3SJ	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
LABETALOL HYDROCHLORIDE	1GEV3BAW9J	ACTIB
FD&C BLUE NO. 1--ALUMINUM LAKE	J9EQA3S2JM	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A207743-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19
A207743-002	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2017-09-19
A207743-003	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207743-001	AB
A207743-002	AB
A207743-003	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 · 132 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
2026-10-15 13:18:30	2026-09	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2017-09-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2017-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB	RS	2017-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207743-002	LABETALOL HYDROCHLORIDE	200MG	TABLET / ORAL	AB		2017-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207743-003	LABETALOL HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2017-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-001	LABETALOL HYDROCHLORIDE	100MG	TABLET / ORAL	AB		2017-09-19	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A207743-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207743-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207743-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207743-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207743-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207743-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207743-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207743-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207743-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207743-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207743-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207743-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207743-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207743-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207743-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207743-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207743-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207743-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207743-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207743-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207743-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207743-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207743-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207743-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207743-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207743-001	AB	1	`79d66fd596c7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Zydus Lifesciences Limited	a3c0cc1e-1c01-4009-afdc-d35a66546aec	2024-11-30		Exact identifier ndc (package): 70771-1163-1 ndc (package): 70771-1164-3 ndc (package): 70771-1163-5 ndc (package): 70771-1165-5 ndc (package): 70771-1164-9 ndc (package): 70771-1163-9 ndc (package): 70771-1164-5 ndc (package): 70771-1164-1 ndc (package): 70771-1163-3 ndc (package): 70771-1165-9 ndc (package): 70771-1165-1 ndc (package): 70771-1165-3 ndc (product): 70771-1165 ndc (product): 70771-1164 ndc (product): 70771-1163 ndc11 (package): 70771116305 ndc11 (package): 70771116401 ndc11 (package): 70771116405 ndc11 (package): 70771116409 ndc11 (package): 70771116503 ndc11 (package): 70771116301 ndc11 (package): 70771116403 ndc11 (package): 70771116509 ndc11 (package): 70771116303 ndc11 (package): 70771116501 ndc11 (package): 70771116505 ndc11 (package): 70771116309 spl id: 2be8d068-1830-4767-9e97-8d774d9a6001 spl set id: a3c0cc1e-1c01-4009-afdc-d35a66546aec

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.