PYRIDOXINE HCI

Product NDC: 51662-1410
11-digit product format: 516621410
Labeler code: 51662
Product ID: 51662-1410_0ffba8c5-bf5d-a665-e063-6294a90a64f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PYRIDOXINE HCI
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA080618
Marketing category: ANDA
Marketing start: 2019-10-08
Substance: PYRIDOXINE HYDROCHLORIDE
Active strength: 100 mg/mL
Pharmacologic classes: Analogs/Derivatives [Chemical/Ingredient], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [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 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
A080618-001	PYRIDOXINE HYDROCHLORIDE	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982

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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: PYRIDOXINE HCI
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PYRIDOXINE HYDROCHLORIDE	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
68Y4CF58BV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312736	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
946c8e50-08d0-755d-e053-2a95a90a84de	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51662-1410-1	PYRIDOXINE HCI	1 mL in 1 VIAL	INJECTION, SOLUTION	1	4
51662-1410-2	PYRIDOXINE HCI	1 mL in 1 VIAL	INJECTION, SOLUTION	1	4
51662-1410-2	PYRIDOXINE HCI	1 in 1 POUCH	INJECTION, SOLUTION	1	4
51662-1410-3	PYRIDOXINE HCI	25 in 1 CASE	INJECTION, SOLUTION	25	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1410	PYRIDOXINE HCI INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	4	Current NDC, Legacy NDC, 4 package rows	20240129_946c8e50-08d0-755d-e053-2a95a90a84de.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pyridoxine Hydrochloride	PYRIDOXINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	a56d11c0-b033-4201-85ff-fc710506481a	2024-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080618 application number: ANDA080618
PYRIDOXINE HCI	PYRIDOXINE HCI	HF Acquisition Co LLC, DBA HealthFirst	946c8e50-08d0-755d-e053-2a95a90a84de	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080618 application number: ANDA080618 ndc (product): 51662-1410

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
68Y4CF58BV	PYRIDOXINE HYDROCHLORIDE	58-56-0	PYRIDOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312736	pyridoxine HCl 100 MG/ML Injectable Solution	PSN	946c8e50-08d0-755d-e053-2a95a90a84de	4
312736	pyridoxine hydrochloride 100 MG/ML Injectable Solution	SCD	946c8e50-08d0-755d-e053-2a95a90a84de	4
312736	vit-B6 Hydrochloride 100 MG/ML Injectable Solution	SY	946c8e50-08d0-755d-e053-2a95a90a84de	4
312736	vitamin B 6 100 MG/ML Injectable Solution	SY	946c8e50-08d0-755d-e053-2a95a90a84de	4
312736	vitamin B6 Hydrochloride 100 MG/ML Injectable Solution	SY	946c8e50-08d0-755d-e053-2a95a90a84de	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1410-1	51662141001	1 mL in 1 VIAL (51662-1410-1)	1 ml	2019-10-08	0000-00-00	No	No	Current
51662-1410-2	51662141002	1 mL in 1 VIAL	1 ml					Historical
51662-1410-3	51662141003	25 POUCH in 1 CASE (51662-1410-3) / 1 VIAL in 1 POUCH (51662-1410-2) / 1 mL in 1 VIAL	25 pouch	2022-12-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PYRIDOXINE HCI INJECTION, USP 100mg per mL 1mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2024-01-28	HUMAN PRESCRIPTION DRUG LABEL	4