PANTOPRAZOLE SODIUM
- Product NDC
- 58517-420
- 11-digit product format
- 585170420
- Labeler code
- 58517
- Product ID
- 58517-420_3488e3d7-1285-4002-b351-15f59623a2eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PANTOPRAZOLE SODIUM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- New Horizon Rx Group, LLC
- Application
- ANDA077058
- Marketing category
- ANDA
- Marketing start
- 2013-08-25
- 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
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 58517-420 | | I | Inactivated by FDA | | 2026-07-31 |
| excluded package | package | 58517-420 | 58517-420-30 | I | Inactivated by FDA | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A077058-001 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | | | 2007-09-10 |
| A077058-002 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | | | 2007-09-10 |
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 |
|---|
| 58517-420-30 | PANTOPRAZOLE SODIUMDelayed Release | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PANTOPRAZOLE SODIUM | ACTIVE INGREDIENT | 6871619Q5X | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| PANTOPRAZOLE | ACTIVE MOIETY | D8TST4O562 | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| SODIUM CARBONATE | INACTIVE INGREDIENT | 45P3261C7T | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58517-420 | PANTOPRAZOLE SODIUM DELAYED RELEASE (PANTOPRAZOLE SODIUM) TABLET [NEW HORIZON RX GROUP, LLC] | 3 | Legacy NDC, 1 package rows | 20131231_1e4edc4d-fa80-4afc-9864-59009764601f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 58517-420-30 | 58517042030 | 30 in 1 BOTTLE | Historical |