Home NDC 61919-866 PANTOPRAZOLE SODIUM
Product NDC 61919-866
11-digit product format 619190866
Labeler code 61919
Product ID 61919-866_6e78bccd-5bee-4ea3-a105-703da1cdc405
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PANTOPRAZOLE SODIUM
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler DirectRX
Application ANDA077058
Marketing category ANDA
Marketing start 2015-01-01
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 61919-866-40 PANTOPRAZOLE SODIUM 40 in 1 BOTTLE TABLET, DELAYED RELEASE 40 2 61919-866-90 PANTOPRAZOLE SODIUM 90 in 1 BOTTLE TABLET, DELAYED RELEASE 90 2
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 [DIRECTRX] 2 PANTOPRAZOLE ACTIVE MOIETY D8TST4O562 PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 AMMONIA INACTIVE INGREDIENT 5138Q19F1X PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 SODIUM CARBONATE INACTIVE INGREDIENT 45P3261C7T PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-866 PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [DIRECTRX] 2 Legacy NDC, 2 package rows 20151113_e0517f55-9810-4302-9b09-82af015c5f50.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 61919-866-40 61919086640 40 in 1 BOTTLE Historical 61919-866-90 61919086690 90 in 1 BOTTLE Historical