Pantoprazole Sodium

Product NDC
85509-1636
11-digit product format
855091636
Labeler code
85509
Product ID
85509-1636_440b9278-eab8-6434-e063-6394a90ac398
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
PHOENIX RX LLC
Application
ANDA205119
Marketing category
ANDA
Marketing start
2016-06-20
Substance
PANTOPRAZOLE SODIUM
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pantoprazole Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANTOPRAZOLE SODIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6871619Q5X
Rxcui251872

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ae9ebba7-ac9e-4a6e-90ef-4bd9760ec041Product name820260304
41d62193-73fc-49cf-9907-add9588e2da1Product name920260112
f12d0d0d-c068-46c6-872c-96c9d38533bbProduct name120250116
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-1636-3Pantoprazole Sodium30 in 1 BOTTLETABLET, DELAYED RELEASE301
85509-1636-6Pantoprazole Sodium60 in 1 BOTTLETABLET, DELAYED RELEASE601
85509-1636-9Pantoprazole Sodium90 in 1 BOTTLETABLET, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1636-3EA - Each85509-1636a9142f5f-3fd7-408e-a2ac-ec13b433de7e12026-01-08
85509-1636-6EA - Each85509-163612ce81c6-780f-468b-92a9-25f4efc1e9ae12026-01-08
85509-1636-9EA - Each85509-1636f850f483-f40e-440b-a33f-ae85147bce1312026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251872pantoprazole sodium 20 MG Delayed Release Oral TabletPSN440b9ae8-2fb8-5d35-e063-6294a90a82b61
251872pantoprazole 20 MG Delayed Release Oral TabletSCD440b9ae8-2fb8-5d35-e063-6294a90a82b61
251872pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral TabletSY440b9ae8-2fb8-5d35-e063-6294a90a82b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85509-1636-38550916360330 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1636-3) 2025-11-20NoNoHistorical
85509-1636-68550916360660 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1636-6) 2025-11-20NoNoHistorical
85509-1636-98550916360990 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1636-9) 2025-11-20NoNoHistorical