Protonix
- Product NDC
- 0008-0844
- 11-digit product format
- 000080844
- Labeler code
- 0008
- Product ID
- 0008-0844_b1adaee5-9353-48ce-bde4-f169a3787e30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PANTOPRAZOLE SODIUM
- Dosage form
- GRANULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Application
- NDA022020
- Marketing category
- NDA
- Marketing start
- 2008-02-29
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Protonix
- Brand name suffix
- Delayed-Release
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PANTOPRAZOLE SODIUM | 40 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 6871619Q5X |
| Rxcui | 251872, 284400, 314200, 352125, 763306, 763308 |
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 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| edf5fdf1-aed1-42ea-b2a8-97b779f9aca4 | Product name | 1 | 20230718 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0008-0844-02 | 2024-01-30 | C162847 | 48780-1 | 1030e364-f951-111a-e063-dadaa90a10e2 | 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, for oral use 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 |
|---|---|---|---|---|---|---|
| 0008-0844-01 | ProtonixDelayed-Release | 1 in 1 PACKET | GRANULE, DELAYED RELEASE | 1 | 48 | |
| 0008-0844-02 | ProtonixDelayed-Release | 30 in 1 CARTON | GRANULE, DELAYED RELEASE | 30 | 48 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0008-0844-01 | EA - Each | 0008-0844 | a4a64248-a74b-44f3-85c5-bfd22d4cd462 | 1 | 2012-07-24 |
| 0008-0844-02 | EA - Each | 0008-0844 | 923dad3a-0648-4fe5-b4ea-526fe7657d8d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0008-0844 | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.] | 47 | Current NDC, Legacy NDC, 2 package rows | 20240719_08098cb2-c048-4640-f387-6beec4a38936.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 251872 | pantoprazole sodium 20 MG Delayed Release Oral Tablet | PSN | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763306 | pantoprazole sodium 40 MG Delayed Release Oral Granules | PSN | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 314200 | pantoprazole sodium 40 MG Delayed Release Oral Tablet | PSN | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 352125 | Protonix 20 MG Delayed Release Oral Tablet | PSN | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763308 | Protonix 40 MG Delayed Release Oral Granules | PSN | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 284400 | Protonix 40 MG Delayed Release Oral Tablet | PSN | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 352125 | pantoprazole 20 MG Delayed Release Oral Tablet [Protonix] | SBD | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 284400 | pantoprazole 40 MG Delayed Release Oral Tablet [Protonix] | SBD | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763308 | pantoprazole 40 MG Oral Granules [Protonix] | SBD | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 251872 | pantoprazole 20 MG Delayed Release Oral Tablet | SCD | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 314200 | pantoprazole 40 MG Delayed Release Oral Tablet | SCD | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763306 | pantoprazole 40 MG Oral Granules | SCD | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 251872 | pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 314200 | pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763306 | pantoprazole 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral Granules | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763306 | pantoprazole 40 MG Enteric Coated Oral Granules for Oral Suspension | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 352125 | Protonix 20 MG Delayed Release Oral Tablet | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 284400 | Protonix 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763308 | Protonix 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral Granules | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 284400 | Protonix 40 MG Delayed Release Oral Tablet | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763308 | Protonix 40 MG Enteric Coated Oral Granules for Oral Suspension | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 763308 | Protonix 40 MG Oral Granules | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
| 352125 | Protonx 20 MG (pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet | SY | 08098cb2-c048-4640-f387-6beec4a38936 | 48 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0008-0844-01 | 00008084401 | 1 in 1 PACKET | Historical | |||||
| 0008-0844-02 | 00008084402 | 30 PACKET in 1 CARTON (0008-0844-02) / 1 GRANULE, DELAYED RELEASE in 1 PACKET (0008-0844-01) | 30 packet | 2008-02-29 | 0000-00-00 | No | No | Current |