Pantoprazole Sodium
- Product NDC
- 50436-0096
- 11-digit product format
- 504360096
- Labeler code
- 50436
- Product ID
- 50436-0096_5ff6264f-9b0d-4eb0-8baa-b5189fb1312d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pantoprazole Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA090074
- Marketing category
- ANDA
- Marketing start
- 2011-01-20
- Marketing end
- 0000-00-00
- Substance
- PANTOPRAZOLE SODIUM
- Active strength
- 20 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ae9ebba7-ac9e-4a6e-90ef-4bd9760ec041 | Product name | 8 | 20260304 |
| 41d62193-73fc-49cf-9907-add9588e2da1 | Product name | 9 | 20260112 |
| f12d0d0d-c068-46c6-872c-96c9d38533bb | Product name | 1 | 20250116 |
| edf5fdf1-aed1-42ea-b2a8-97b779f9aca4 | Product name | 1 | 20230718 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-0096-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e060-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-0096-2 | Pantoprazole Sodium | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-0096-2 | EA - Each | 50436-0096 | 2aa72944-d9e4-426b-8104-81a38cfd1d54 | 1 | 2018-05-09 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-0096 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES] | 3 | Legacy NDC, 1 package rows | 20180929_8fbb2e3d-6354-401d-a403-b2541081e096.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 251872 | pantoprazole sodium 20 MG Delayed Release Oral Tablet | PSN | 8fbb2e3d-6354-401d-a403-b2541081e096 | 3 |
| 314200 | pantoprazole sodium 40 MG Delayed Release Oral Tablet | PSN | 8fbb2e3d-6354-401d-a403-b2541081e096 | 3 |
| 251872 | pantoprazole 20 MG Delayed Release Oral Tablet | SCD | 8fbb2e3d-6354-401d-a403-b2541081e096 | 3 |
| 314200 | pantoprazole 40 MG Delayed Release Oral Tablet | SCD | 8fbb2e3d-6354-401d-a403-b2541081e096 | 3 |
| 251872 | pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | 8fbb2e3d-6354-401d-a403-b2541081e096 | 3 |
| 314200 | pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet | SY | 8fbb2e3d-6354-401d-a403-b2541081e096 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-0096-2 | 50436009602 | 60 in 1 BOTTLE | Historical |