Protonix
- Product NDC
- 55154-4232
- 11-digit product format
- 551544232
- Labeler code
- 55154
- Product ID
- 55154-4232_2fd2b436-0be8-4f80-8554-2f663bc8af80
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pantoprazole sodium
- Dosage form
- GRANULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- NDA022020
- Marketing category
- NDA
- Marketing start
- 2008-02-29
- 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
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PANTOPRAZOLE SODIUM | ACTIVE INGREDIENT | 6871619Q5X | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| PANTOPRAZOLE | ACTIVE MOIETY | D8TST4O562 | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| HYPROMELLOSE 2910 (5 MPA.S) | INACTIVE INGREDIENT | R75537T0T4 | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| POVIDONE K25 | INACTIVE INGREDIENT | K0KQV10C35 | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| POVIDONE K90 | INACTIVE INGREDIENT | RDH86HJV5Z | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-4232 | PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH 107, LLC] | 14 | Legacy NDC | 20241013_189b7b6a-9717-44eb-b87b-fd3e985b2268.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55154-4232-0 | 55154423200 | 10 PACKET in 1 BAG (55154-4232-0) > 40 GRANULE, DELAYED RELEASE in 1 PACKET | 10 packet | 2008-02-29 | 0000-00-00 | No | No | Current |