Protonix
- Product NDC
- 0008-4001
- 11-digit product format
- 000084001
- Labeler code
- 0008
- Product ID
- 0008-4001_d36cd2fb-517f-44e5-8438-53e563775f86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PANTOPRAZOLE SODIUM
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Application
- NDA020988
- Marketing category
- NDA
- Marketing start
- 2013-05-01
- Substance
- PANTOPRAZOLE SODIUM
- Active strength
- 40 mg/10mL
- Pharmacologic classes
- Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Protonix
- Brand name suffix
- I.V.
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PANTOPRAZOLE SODIUM | 40 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6871619Q5X |
| Rxcui | 283669, 885257 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0008-4001-01 | ProtonixI.V. | 10 mL in 1 VIAL | INJECTION, POWDER, FOR SOLUTION | 10 | | 24 |
| 0008-4001-01 | ProtonixI.V. | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | | 24 |
| 0008-4001-10 | ProtonixI.V. | 10 in 1 PACKAGE | INJECTION, POWDER, FOR SOLUTION | 10 | | 24 |
| 0008-4001-25 | ProtonixI.V. | 25 in 1 PACKAGE | INJECTION, POWDER, FOR SOLUTION | 25 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PANTOPRAZOLE SODIUM | ACTIVE INGREDIENT | 6871619Q5X | PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 5 | |
| PANTOPRAZOLE | ACTIVE MOIETY | D8TST4O562 | PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 5 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 5 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0008-4001 | PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.] | 23 | Current NDC, Legacy NDC, 4 package rows | 20250228_f39b3e7d-39d2-4c8a-9974-4ab885241880.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0008-4001-01 | 00008400101 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 0008-4001-10 | 00008400110 | 10 CARTON in 1 PACKAGE (0008-4001-10) / 1 VIAL in 1 CARTON (0008-4001-01) / 10 mL in 1 VIAL | 10 carton | 2013-05-01 | 0000-00-00 | No | No | Current |
| 0008-4001-25 | 00008400125 | 25 CARTON in 1 PACKAGE (0008-4001-25) / 1 VIAL in 1 CARTON (0008-4001-01) / 10 mL in 1 VIAL | 25 carton | 2013-05-01 | 0000-00-00 | No | No | Current |