Pantoprazole Sodium
- Product NDC
- 43353-338
- 11-digit product format
- 433530338
- Labeler code
- 43353
- Product ID
- 43353-338_d210a49a-4415-4bb1-b333-8027e459711b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pantoprazole sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA020987
- Marketing category
- NDA
- Marketing start
- 2008-01-31
- 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 |
|---|
| 43353-338-09 | Pantoprazole Sodium Delayed-Release | 9000 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 9000 | | 3 |
| 43353-338-30 | Pantoprazole Sodium Delayed-Release | 30 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 30 | | 3 |
| 43353-338-53 | Pantoprazole Sodium Delayed-Release | 60 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 60 | | 3 |
| 43353-338-60 | Pantoprazole Sodium Delayed-Release | 90 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 90 | | 3 |
| 43353-338-79 | Pantoprazole Sodium Delayed-Release | 2160 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 2160 | | 3 |
| 43353-338-88 | Pantoprazole Sodium Delayed-Release | 900 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 900 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PANTOPRAZOLE SODIUM | ACTIVE INGREDIENT | 6871619Q5X | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| PANTOPRAZOLE | ACTIVE MOIETY | D8TST4O562 | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| HYPROMELLOSE 2208 (100 MPA.S) | INACTIVE INGREDIENT | B1QE5P712K | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| POVIDONE K25 | INACTIVE INGREDIENT | K0KQV10C35 | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| POVIDONE K90 | INACTIVE INGREDIENT | RDH86HJV5Z | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-338 | PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | Legacy NDC, 6 package rows | 20140422_03974abc-ad03-44da-b7b6-d8e6c4a06105.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43353-338-09 | 43353033809 | 9000 in 1 BOTTLE, PLASTIC | Historical |
| 43353-338-30 | 43353033830 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 43353-338-53 | 43353033853 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 43353-338-60 | 43353033860 | 90 in 1 BOTTLE, PLASTIC | Historical |
| 43353-338-79 | 43353033879 | 2160 in 1 BOTTLE, PLASTIC | Historical |
| 43353-338-88 | 43353033888 | 900 in 1 BOTTLE, PLASTIC | Historical |