Labetalol HCl in Sodium Chloride

Product NDC: 0143-9364
11-digit product format: 001439364
Labeler code: 0143
Product ID: 0143-9364_d0e3d92d-d96e-4d5e-98ca-3d18a4bc82d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LABETALOL HYDROCHLORIDE
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: NDA213330
Marketing category: NDA
Marketing start: 2020-11-09
Substance: LABETALOL HYDROCHLORIDE
Active strength: 1 mg/mL
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N213330-001	LABETALOL HYDROCHLORIDE IN DEXTROSE	LABETALOL HYDROCHLORIDE	200MG/200ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09
N213330-002	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	LABETALOL HYDROCHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09
N213330-003	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	LABETALOL HYDROCHLORIDE	200MG/200ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09
N213330-004	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	LABETALOL HYDROCHLORIDE	300MG/300ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09
N213330-005	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-03-18
N213330-006	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	20MG/4ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-08-19

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 · 188 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N213330-001	LABETALOL HYDROCHLORIDE IN DEXTROSE	200MG/200ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213330-002	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213330-003	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	200MG/200ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213330-004	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	300MG/300ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213330-005	LABETALOL HYDROCHLORIDE	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213330-006	LABETALOL HYDROCHLORIDE	20MG/4ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-08-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213330-001	LABETALOL HYDROCHLORIDE IN DEXTROSE	200MG/200ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213330-002	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213330-003	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	200MG/200ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213330-004	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	300MG/300ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213330-005	LABETALOL HYDROCHLORIDE	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213330-006	LABETALOL HYDROCHLORIDE	20MG/4ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213330-001	LABETALOL HYDROCHLORIDE IN DEXTROSE	200MG/200ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213330-002	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213330-003	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	200MG/200ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213330-004	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	300MG/300ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213330-005	LABETALOL HYDROCHLORIDE	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213330-006	LABETALOL HYDROCHLORIDE	20MG/4ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213330-001	LABETALOL HYDROCHLORIDE IN DEXTROSE	200MG/200ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213330-002	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213330-003	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	200MG/200ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213330-004	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	300MG/300ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213330-005	LABETALOL HYDROCHLORIDE	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-03-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213330-006	LABETALOL HYDROCHLORIDE	20MG/4ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213330-001	LABETALOL HYDROCHLORIDE IN DEXTROSE	200MG/200ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213330-002	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213330-003	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	200MG/200ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213330-004	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	300MG/300ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213330-005	LABETALOL HYDROCHLORIDE	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-03-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213330-006	LABETALOL HYDROCHLORIDE	20MG/4ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213330-001	LABETALOL HYDROCHLORIDE IN DEXTROSE	200MG/200ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213330-002	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213330-003	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	200MG/200ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213330-004	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	300MG/300ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213330-005	LABETALOL HYDROCHLORIDE	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2022-03-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213330-006	LABETALOL HYDROCHLORIDE	20MG/4ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213330-001	LABETALOL HYDROCHLORIDE IN DEXTROSE	200MG/200ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213330-002	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	100MG/100ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213330-003	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	200MG/200ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213330-004	LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE	300MG/300ML (1MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2020-11-09	`03ed91905a0d…`

Additional Listing Data#

Finished product: Yes
Brand name base: Labetalol HCl in Sodium Chloride
Listing expiration: 2026-12-31

Active Ingredients#

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

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
2477889	Internal RxNorm lookup
2479564	Internal RxNorm lookup
2479566	Internal RxNorm lookup
2479567	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
99a715a0-4579-410c-b102-7ef6fab8db55	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
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
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0143-9364-01	Labetalol HCl in Sodium Chloride	200 mL in 1 BAG	INJECTION	200		9
0143-9364-10	Labetalol HCl in Sodium Chloride	10 in 1 BOX	INJECTION	10		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9364-01	ML - Milliliter	0143-9364	8bf26f85-bd93-4a30-9bba-419f83e4fa66	1	2021-05-05
0143-9364-10	ML - Milliliter	0143-9364	5592951b-b717-40f8-be0b-f6048fc96989	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9364	LABETALOL HCL IN SODIUM CHLORIDE (LABETALOL HYDROCHLORIDE) INJECTION LABETALOL HCL IN DEXTROSE (LABETALOL HYDROCHLORIDE) INJECTION LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]	8	Current NDC, Legacy NDC, 2 package rows	20250131_99a715a0-4579-410c-b102-7ef6fab8db55.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Labetalol Hydrochloride	LABETALOL HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	99a715a0-4579-410c-b102-7ef6fab8db55	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213330 application number: NDA213330 ndc (product): 0143-9364

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
2477889	labetalol HCl 20 MG in 4 ML Injection	PSN	99a715a0-4579-410c-b102-7ef6fab8db55	9
2479566	labetalol hydrochloride 100 MG in 100 ML Injection	PSN	99a715a0-4579-410c-b102-7ef6fab8db55	9
2479564	labetalol hydrochloride 200 MG in 200 ML Injection	PSN	99a715a0-4579-410c-b102-7ef6fab8db55	9
2479567	labetalol hydrochloride 300 MG in 300 ML Injection	PSN	99a715a0-4579-410c-b102-7ef6fab8db55	9
2479566	100 ML labetalol hydrochloride 1 MG/ML Injection	SCD	99a715a0-4579-410c-b102-7ef6fab8db55	9
2479564	200 ML labetalol hydrochloride 1 MG/ML Injection	SCD	99a715a0-4579-410c-b102-7ef6fab8db55	9
2479567	300 ML labetalol hydrochloride 1 MG/ML Injection	SCD	99a715a0-4579-410c-b102-7ef6fab8db55	9
2477889	4 ML labetalol hydrochloride 5 MG/ML Injection	SCD	99a715a0-4579-410c-b102-7ef6fab8db55	9
2477889	labetalol HCl 20 MG per 4 ML Injection	SY	99a715a0-4579-410c-b102-7ef6fab8db55	9
2479566	labetalol hydrochloride 100 MG per 100 ML Injection	SY	99a715a0-4579-410c-b102-7ef6fab8db55	9
2479564	labetalol hydrochloride 200 MG per 200 ML Injection	SY	99a715a0-4579-410c-b102-7ef6fab8db55	9
2479567	labetalol hydrochloride 300 MG per 300 ML Injection	SY	99a715a0-4579-410c-b102-7ef6fab8db55	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9364-01	00143936401	200 mL in 1 BAG	200 ml					Historical
0143-9364-10	00143936410	10 BAG in 1 BOX (0143-9364-10) / 200 mL in 1 BAG (0143-9364-01)	10 bag	2020-11-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Labetalol HCl in Sodium Chloride	Hikma Pharmaceuticals USA Inc.	2025-12-19	HUMAN PRESCRIPTION DRUG LABEL	9