LABETALOL HYDROCHLORIDE

Product NDC: 51662-1228
11-digit product format: 516621228
Labeler code: 51662
Product ID: 51662-1228_9f03d200-e490-fed3-e053-2a95a90a698a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LABETALOL HYDROCHLORIDE
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA075240
Marketing category: ANDA
Marketing start: 2018-09-14
Marketing end: 0000-00-00
Substance: LABETALOL HYDROCHLORIDE
Active strength: 5 mg/mL
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51662-1228		I	Inactivated by FDA	2026-08-07
excluded package	package	51662-1228	51662-1228-1	I	Inactivated by FDA	2026-08-07
excluded package	package	51662-1228	51662-1228-9	I	Inactivated by FDA	2026-08-07

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 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51662-1228-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51662-1228-9	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51662-1228-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51662-1228-9	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51662-1228-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51662-1228-9	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51662-1228-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51662-1228-9	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51662-1228-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51662-1228-9	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51662-1228-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51662-1228-9	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51662-1228-9	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51662-1228-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51662-1228-9	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51662-1228-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51662-1228-9	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51662-1228-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075240-001	LABETALOL HYDROCHLORIDE	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075240-001	AP

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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075240-001	LABETALOL HYDROCHLORIDE	5MG/ML	INJECTABLE / INJECTION	AP	RS	1999-11-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A075240-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075240-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075240-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075240-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075240-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075240-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075240-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075240-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075240-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075240-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075240-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075240-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075240-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075240-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075240-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075240-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075240-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075240-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075240-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075240-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075240-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075240-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075240-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075240-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075240-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075240-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075240-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075240-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075240-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075240-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075240-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075240-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075240-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075240-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075240-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075240-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075240-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075240-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075240-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075240-001	AP	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
51662-1228-1	2025-01-30	LABETALOL HYDROCHLORIDE INJECTION, USP 100mg/20mL (5mg/mL) VIAL
51662-1228-9	2025-01-30	LABETALOL HYDROCHLORIDE INJECTION, USP 100mg/20mL (5mg/mL) VIAL
51662-1228-1	2020-02-07	LABETALOL HYDROCHLORIDE INJECTION, USP 100mg/20mL (5mg/mL) VIAL
51662-1228-9	2020-02-07	LABETALOL HYDROCHLORIDE INJECTION, USP 100mg/20mL (5mg/mL) VIAL
51662-1228-1	2020-01-31	LABETALOL HYDROCHLORIDE INJECTION, USP 100mg/20mL (5mg/mL) VIAL
51662-1228-9	2020-01-31	LABETALOL HYDROCHLORIDE INJECTION, USP 100mg/20mL (5mg/mL) VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51662-1228-1	LABETALOL HYDROCHLORIDE	1 in 1 CARTON	INJECTION, SOLUTION	1	6
51662-1228-1	LABETALOL HYDROCHLORIDE	20 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	20	6
51662-1228-9	LABETALOL HYDROCHLORIDE	20 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	20	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1228	LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	6	Legacy NDC, 3 package rows	20200221_75d74177-4e71-cef2-e053-2991aa0a9a97.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	Hospira, Inc.	abfc6b75-1ed5-41f1-0484-4597488237bc	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075240 application number: ANDA075240

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
896771	labetalol HCl 5 MG/ML Injectable Solution	PSN	75d74177-4e71-cef2-e053-2991aa0a9a97	6
896771	labetalol hydrochloride 5 MG/ML Injectable Solution	SCD	75d74177-4e71-cef2-e053-2991aa0a9a97	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1228-1	51662122801	1 VIAL, MULTI-DOSE in 1 CARTON (51662-1228-1) > 20 mL in 1 VIAL, MULTI-DOSE		2018-09-14	0000-00-00	No	No	Current
51662-1228-9	51662122809	20 mL in 1 VIAL, MULTI-DOSE (51662-1228-9)	20 ml	2018-09-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LABETALOL HYDROCHLORIDE INJECTION, USP 100mg/20mL (5mg/mL) VIAL	HF Acquisition Co LLC, DBA HealthFirst	2020-02-20	HUMAN PRESCRIPTION DRUG LABEL	6