Pyridoxine Hydrochloride

Product NDC
63323-180
11-digit product format
633230180
Labeler code
63323
Product ID
63323-180_621c0b5c-be50-4bb5-9475-6acba6114cbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PYRIDOXINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA080618
Marketing category
ANDA
Marketing start
1972-08-14
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

Additional Listing Data#

Finished product
Yes
Brand name base
Pyridoxine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRIDOXINE HYDROCHLORIDE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii68Y4CF58BV
Rxcui312736

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-180-00Pyridoxine Hydrochloride1 mL in 1 VIALINJECTION, SOLUTION15
63323-180-01Pyridoxine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-180-00ML - Milliliter63323-1807052aeef-26c5-4743-87c6-6ad00f50af5012021-03-02
63323-180-01ML - Milliliter63323-180b8d915a6-5720-44e9-9e88-4201e7c8de0312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BVPYRIDOXINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6ZPYRIDOXINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCPYRIDOXINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPYRIDOXINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-180PYRIDOXINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 2 package rows20241019_a56d11c0-b033-4201-85ff-fc710506481a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312736pyridoxine HCl 100 MG/ML Injectable SolutionPSNa56d11c0-b033-4201-85ff-fc710506481a5
312736pyridoxine hydrochloride 100 MG/ML Injectable SolutionSCDa56d11c0-b033-4201-85ff-fc710506481a5
312736vit-B6 Hydrochloride 100 MG/ML Injectable SolutionSYa56d11c0-b033-4201-85ff-fc710506481a5
312736vitamin B 6 100 MG/ML Injectable SolutionSYa56d11c0-b033-4201-85ff-fc710506481a5
312736vitamin B6 Hydrochloride 100 MG/ML Injectable SolutionSYa56d11c0-b033-4201-85ff-fc710506481a5
312736pyridoxine HCl 100 MG/ML Injectable SolutionPSN946c8e50-08d0-755d-e053-2a95a90a84de4
312736pyridoxine hydrochloride 100 MG/ML Injectable SolutionSCD946c8e50-08d0-755d-e053-2a95a90a84de4
312736vit-B6 Hydrochloride 100 MG/ML Injectable SolutionSY946c8e50-08d0-755d-e053-2a95a90a84de4
312736vitamin B 6 100 MG/ML Injectable SolutionSY946c8e50-08d0-755d-e053-2a95a90a84de4
312736vitamin B6 Hydrochloride 100 MG/ML Injectable SolutionSY946c8e50-08d0-755d-e053-2a95a90a84de4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-180-00633230180001 mL in 1 VIAL1 mlHistorical
63323-180-016332301800125 VIAL in 1 TRAY (63323-180-01) / 1 mL in 1 VIAL (63323-180-00) 25 vial2000-09-050000-00-00NoNoCurrent