Pantoprazole Sodium
- Product NDC
- 50268-636
- 11-digit product format
- 502680636
- Labeler code
- 50268
- Product ID
- 50268-636_d5df0080-3135-e8c7-e053-2a95a90aa130
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pantoprazole Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA078281
- Marketing category
- ANDA
- Marketing start
- 2013-01-23
- Marketing end
- 2023-03-31
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-636-11 | Pantoprazole Sodium | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | | 13 |
| 50268-636-15 | Pantoprazole Sodium | 50 in 1 BOX | TABLET, DELAYED RELEASE | 50 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PANTOPRAZOLE SODIUM | ACTIVE INGREDIENT | 6871619Q5X | PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK] | 5 | |
| PANTOPRAZOLE | ACTIVE MOIETY | D8TST4O562 | PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK] | 5 | |
| crospovidone | INACTIVE INGREDIENT | 68401960MK | PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK] | 5 | |
| glyceryl dibehenate | INACTIVE INGREDIENT | R8WTH25YS2 | PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK] | 5 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK] | 5 | |
| isopropyl alcohol | INACTIVE INGREDIENT | ND2M416302 | PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK] | 5 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK] | 5 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK] | 5 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK] | 5 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK] | 5 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK] | 5 | |
| triethyl citrate | INACTIVE INGREDIENT | 8Z96QXD6UM | PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-636 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AVPAK] | 12 | Legacy NDC, 2 package rows | 20220913_dcac4022-fea1-67c5-3331-fefcc3c440d8.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 |
|---|
| 50268-636-11 | 50268063611 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50268-636-15 | 50268063615 | 50 BLISTER PACK in 1 BOX (50268-636-15) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-636-11) | 50 blister pack | 2013-01-23 | 0000-00-00 | No | No | Current |