Pantoprazole Sodium
- Product NDC
- 0615-7629
- 11-digit product format
- 006157629
- Labeler code
- 0615
- Product ID
- 0615-7629_344482ad-3ddc-4be8-9fb7-a93c355a1778
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pantoprazole sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA090970
- Marketing category
- ANDA
- Marketing start
- 2011-01-19
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pantoprazole Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PANTOPRAZOLE SODIUM | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6871619Q5X |
| Rxcui | 314200 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-7629-05 | Pantoprazole Sodium | 15 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 15 | | 21 |
| 0615-7629-07 | Pantoprazole Sodium | 7 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 7 | | 21 |
| 0615-7629-14 | Pantoprazole Sodium | 14 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 14 | | 21 |
| 0615-7629-28 | Pantoprazole Sodium | 28 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 28 | | 21 |
| 0615-7629-30 | Pantoprazole Sodium | 6 in 1 BOX, UNIT-DOSE | TABLET, DELAYED RELEASE | 6 | | 21 |
| 0615-7629-30 | Pantoprazole Sodium | 5 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 5 | | 21 |
| 0615-7629-39 | Pantoprazole Sodium | 30 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 30 | | 21 |
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 [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 5 | |
| PANTOPRAZOLE | ACTIVE MOIETY | D8TST4O562 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 5 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 5 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 5 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 5 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 5 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 5 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 5 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 5 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-7629 | PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 21 | Current NDC, Legacy NDC, 7 package rows | 20240921_6faf465b-c3a3-4ae7-9e16-1ba758f6962a.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 |
|---|
| 0615-7629-05 | 00615762905 | 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-7629-05) | | 2022-04-06 | 0000-00-00 | No | No | Current |
| 0615-7629-07 | 00615762907 | 7 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-7629-07) | | 2022-04-06 | 0000-00-00 | No | No | Current |
| 0615-7629-14 | 00615762914 | 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-7629-14) | | 2022-04-06 | 0000-00-00 | No | No | Current |
| 0615-7629-28 | 00615762928 | 28 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-7629-28) | | 2024-04-24 | | No | No | Historical |
| 0615-7629-30 | 00615762930 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7629-30) / 5 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 6 blister pack | 2022-04-11 | 0000-00-00 | No | No | Current |
| 0615-7629-39 | 00615762939 | 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-7629-39) | | 2022-04-06 | 0000-00-00 | No | No | Current |