Pantoprazole Sodium
- Product NDC
- 63187-042
- 11-digit product format
- 631870042
- Labeler code
- 63187
- Product ID
- 63187-042_c7ece449-f294-4adc-9a34-460138bb6e07
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pantoprazole Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA090797
- Marketing category
- ANDA
- Marketing start
- 2011-02-08
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PANTOPRAZOLE SODIUM | ACTIVE INGREDIENT | 6871619Q5X | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| PANTOPRAZOLE | ACTIVE MOIETY | D8TST4O562 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER | INACTIVE INGREDIENT | 905HNO1SIH | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| METHACRYLIC ACID | INACTIVE INGREDIENT | 1CS02G8656 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-042 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 5 | Legacy NDC | 20191121_7229ffef-6017-4a37-a04b-868700d38b6a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-042-30 | 63187004230 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-042-30) | 2018-11-01 | 0000-00-00 | No | No | Current |
| 63187-042-60 | 63187004260 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-042-60) | 2018-11-01 | 0000-00-00 | No | No | Current |
| 63187-042-90 | 63187004290 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-042-90) | 2018-11-01 | 0000-00-00 | No | No | Current |