Pantoprazole Sodium
- Product NDC
- 53808-0957
- 11-digit product format
- 538080957
- Labeler code
- 53808
- Product ID
- 53808-0957_13f84dd6-0543-485f-a14e-b830a4f29c2d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pantoprazole Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA090797
- 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
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 53808-0957-1 | 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 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | INACTIVE INGREDIENT | 905HNO1SIH | 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 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| METHACRYLIC ACID | INACTIVE INGREDIENT | 1CS02G8656 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 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 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 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 |
|---|
| 53808-0957 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20141007_a3417266-502f-4a8e-861e-baef8642bed4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53808-0957-1 | 53808095701 | 30 in 1 BLISTER PACK | Historical |