Application 080618

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PYRIDOXINE HYDROCHLORIDE	PYRIDOXINE HYDROCHLORIDE	INJECTABLE;INJECTION	100MG/ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
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…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080618-001	PYRIDOXINE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a50c72e98297…`

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 ndc (product): 63323-180
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

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1410	PYRIDOXINE HCI	PYRIDOXINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1410	PYRIDOXINE HCI	PYRIDOXINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1410	PYRIDOXINE HCI	PYRIDOXINE HCI	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
63323-180	Pyridoxine Hydrochloride	PYRIDOXINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current
63323-180	Pyridoxine Hydrochloride	PYRIDOXINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	ANDA	Current