Pantoprazole sodium
- Product NDC
- 64679-434
- 11-digit product format
- 646790434
- Labeler code
- 64679
- Product ID
- 64679-434_b7776604-2269-3fef-e053-2995a90ad5b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pantoprazole sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Wockhardt USA LLC.
- Application
- ANDA091231
- Marketing category
- ANDA
- Marketing start
- 2011-01-19
- 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
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
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 [WOCKHARDT USA LLC.] | 2 | |
| PANTOPRAZOLE | ACTIVE MOIETY | D8TST4O562 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64679-434 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [WOCKHARDT USA LLC.] | 6 | Legacy NDC | 20201228_b341ddf9-a539-4e29-b72c-e8f5cc247172.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64679-434-01 | 64679043401 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (64679-434-01) | | 2011-01-19 | 0000-00-00 | No | No | Current |
| 64679-434-02 | 64679043402 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (64679-434-02) | | 2011-01-19 | 0000-00-00 | No | No | Current |
| 64679-434-03 | 64679043403 | 100 BLISTER PACK in 1 CARTON (64679-434-03) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 100 blister pack | 2011-01-19 | 0000-00-00 | No | No | Current |
| 64679-434-04 | 64679043404 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (64679-434-04) | | 2011-01-19 | 0000-00-00 | No | No | Current |
| 64679-434-05 | 64679043405 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (64679-434-05) | | 2011-01-19 | 0000-00-00 | No | No | Current |