Home NDC 53808-1047 Pantoprazole Sodium
Product NDC 53808-1047
11-digit product format 538081047
Labeler code 53808
Product ID 53808-1047_7e19a290-e67f-4925-8efc-30bb45d9f0d7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pantoprazole Sodium
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler State of Florida DOH Central Pharmacy
Application ANDA077058
Marketing category ANDA
Marketing start 2014-01-01
Marketing end 0000-00-00
Substance PANTOPRAZOLE SODIUM
Active strength 40 mg/1
Pharmacologic classes Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077058-001 PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 20MG BASE TABLET, DELAYED RELEASE / ORAL 2007-09-10 A077058-002 PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE TABLET, DELAYED RELEASE / ORAL 2007-09-10
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.
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 2026-08-01 22:54:32 2026-06 A077058-001 PANTOPRAZOLE SODIUM EQ 20MG BASE TABLET, DELAYED RELEASE / ORAL 2007-09-10 a50c72e98297…2026-08-01 22:54:32 2026-06 A077058-002 PANTOPRAZOLE SODIUM EQ 40MG BASE TABLET, DELAYED RELEASE / ORAL 2007-09-10 a50c72e98297…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53808-1047-1 Pantoprazole Sodium 30 in 1 BLISTER PACK TABLET, DELAYED RELEASE 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PANTOPRAZOLE SODIUM ACTIVE INGREDIENT 6871619Q5X PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 PANTOPRAZOLE ACTIVE MOIETY D8TST4O562 PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53808-1047 PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 Legacy NDC, 1 package rows 20141007_92406226-6c32-4b51-bcfa-0a2746b1f78f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 53808-1047-1 53808104701 30 in 1 BLISTER PACK Historical