PANTOPRAZOLE SODIUM
- Product NDC
- 55648-434
- 11-digit product format
- 556480434
- Labeler code
- 55648
- Product ID
- 55648-434_ff0dc161-4748-415c-ba20-bdfff819c611
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PANTOPRAZOLE SODIUM
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- WOCKHARDT LIMITED
- Application
- ANDA091231
- Marketing category
- ANDA
- Marketing start
- 2011-01-19
- 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
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 55648-434-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d958-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use pantoprazole sodium delayed-release tablets, USP safely and effectively. See full prescribing information for pantoprazole sodium delayed-release tablets, USP. Pantoprazole Sodium Delayed-Release Tablets, USP Initial U.S. approval: 2000 |
| 55648-434-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d958-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use pantoprazole sodium delayed-release tablets, USP safely and effectively. See full prescribing information for pantoprazole sodium delayed-release tablets, USP. Pantoprazole Sodium Delayed-Release Tablets, USP Initial U.S. approval: 2000 |
| 55648-434-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d958-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use pantoprazole sodium delayed-release tablets, USP safely and effectively. See full prescribing information for pantoprazole sodium delayed-release tablets, USP. Pantoprazole Sodium Delayed-Release Tablets, USP Initial U.S. approval: 2000 |
| 55648-434-04 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d958-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use pantoprazole sodium delayed-release tablets, USP safely and effectively. See full prescribing information for pantoprazole sodium delayed-release tablets, USP. Pantoprazole Sodium Delayed-Release Tablets, USP Initial U.S. approval: 2000 |
| 55648-434-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d958-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use pantoprazole sodium delayed-release tablets, USP safely and effectively. See full prescribing information for pantoprazole sodium delayed-release tablets, USP. Pantoprazole Sodium Delayed-Release Tablets, USP Initial U.S. approval: 2000 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55648-434-01 | PANTOPRAZOLE SODIUM | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 2 |
| 55648-434-02 | PANTOPRAZOLE SODIUM | 1000 in 1 BOTTLE | TABLET, DELAYED RELEASE | 1000 | | 2 |
| 55648-434-03 | PANTOPRAZOLE SODIUM | 10 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 10 | | 2 |
| 55648-434-03 | PANTOPRAZOLE SODIUM | 100 in 1 CARTON | TABLET, DELAYED RELEASE | 100 | | 2 |
| 55648-434-04 | PANTOPRAZOLE SODIUM | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 2 |
| 55648-434-05 | PANTOPRAZOLE SODIUM | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55648-434 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT LIMITED] | 2 | Legacy NDC, 6 package rows | 20110128_ee114ab9-db51-4a71-90b9-cd9865e4fced.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 55648-434-01 | 55648043401 | 30 in 1 BOTTLE | Historical |
| 55648-434-02 | 55648043402 | 1000 in 1 BOTTLE | Historical |
| 55648-434-03 | 55648043403 | 10 in 1 BLISTER PACK | Historical |
| 55648-434-04 | 55648043404 | 90 in 1 BOTTLE | Historical |
| 55648-434-05 | 55648043405 | 100 in 1 BOTTLE | Historical |