Protonix
- Product NDC
- 69189-0841
- 11-digit product format
- 691890841
- Labeler code
- 69189
- Product ID
- 69189-0841_9b04facd-97eb-4e60-8ded-f4c97251427b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PANTOPRAZOLE SODIUM
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Avera McKennan Hospital
- Application
- NDA020987
- Marketing category
- NDA
- Marketing start
- 2015-09-21
- 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
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 |
|---|---|---|---|---|---|
| 69189-0841-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-abd6-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use PROTONIX safely and effectively. See full prescribing information for PROTONIX. PROTONIX (pantoprazole sodium) delayed-release tablets PROTONIX (pantoprazole sodium) for delayed-release oral suspension Initial U.S. approval: 2000 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69189-0841-1 | Protonix Delayed-Release | 1 in 1 DOSE PACK | TABLET, DELAYED RELEASE | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69189-0841 | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL] | 1 | Legacy NDC, 1 package rows | 20151218_efd8122a-021b-4e1d-a805-37e736738424.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314200 | pantoprazole sodium 40 MG Delayed Release Oral Tablet | PSN | efd8122a-021b-4e1d-a805-37e736738424 | 1 |
| 284400 | Protonix 40 MG Delayed Release Oral Tablet | PSN | efd8122a-021b-4e1d-a805-37e736738424 | 1 |
| 284400 | pantoprazole 40 MG Delayed Release Oral Tablet [Protonix] | SBD | efd8122a-021b-4e1d-a805-37e736738424 | 1 |
| 314200 | pantoprazole 40 MG Delayed Release Oral Tablet | SCD | efd8122a-021b-4e1d-a805-37e736738424 | 1 |
| 314200 | pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet | SY | efd8122a-021b-4e1d-a805-37e736738424 | 1 |
| 284400 | Protonix 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet | SY | efd8122a-021b-4e1d-a805-37e736738424 | 1 |
| 284400 | Protonix 40 MG Delayed Release Oral Tablet | SY | efd8122a-021b-4e1d-a805-37e736738424 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 69189-0841-1 | 69189084101 | 1 in 1 DOSE PACK | Historical |