Prilosec OTC
- Product NDC
- 37000-455
- 11-digit product format
- 370000455
- Labeler code
- 37000
- Product ID
- 37000-455_401e1256-05e3-d4a9-e063-6294a90adce4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- omeprazole magnesium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- The Procter & Gamble Manufacturing Company
- Application
- NDA021229
- Marketing category
- NDA
- Marketing start
- 2003-07-14
- Substance
- OMEPRAZOLE MAGNESIUM
- Active strength
- 20.6 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], 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
- Prilosec OTC
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEPRAZOLE MAGNESIUM | 20.6 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 426QFE7XLK |
| Rxcui | 402014, 608796 |
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 |
|---|
| 37000-455-01 | Prilosec OTC | 1 in 1 POUCH | TABLET, DELAYED RELEASE | 1 | | 16 |
| 37000-455-02 | Prilosec OTC | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | | 16 |
| 37000-455-02 | Prilosec OTC | 14 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 14 | | 16 |
| 37000-455-03 | Prilosec OTC | 2 in 1 CARTON | TABLET, DELAYED RELEASE | 2 | | 16 |
| 37000-455-03 | Prilosec OTC | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | | 16 |
| 37000-455-04 | Prilosec OTC | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | | 16 |
| 37000-455-04 | Prilosec OTC | 3 in 1 CARTON | TABLET, DELAYED RELEASE | 3 | | 16 |
| 37000-455-05 | Prilosec OTC | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| omeprazole magnesium | ACTIVE INGREDIENT | 426QFE7XLK | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | |
| omeprazole magnesium | ACTIVE INGREDIENT | 426QFE7XLK | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| omeprazole | ACTIVE MOIETY | KG60484QX9 | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | |
| omeprazole | ACTIVE MOIETY | KG60484QX9 | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | |
| PARAFFIN | INACTIVE INGREDIENT | I9O0E3H2ZE | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PARAFFIN | INACTIVE INGREDIENT | I9O0E3H2ZE | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PROCTER & GAMBLE MANUFACTURING COMPANY] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 37000-455 | PRILOSEC OTC (OMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [THE PROCTER & GAMBLE MANUFACTURING COMPANY] | 15 | Current NDC, Legacy NDC, 8 package rows | 20241012_77ed80a2-a482-4838-ac55-4865b5c31d9f.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 |
|---|
| 37000-455-01 | 37000045501 | 1 TABLET, DELAYED RELEASE in 1 POUCH (37000-455-01) | | 2003-07-14 | 0000-00-00 | No | No | Current |
| 37000-455-02 | 37000045502 | 1 BLISTER PACK in 1 CARTON (37000-455-02) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 1 blister pack | 2003-07-14 | 0000-00-00 | No | No | Current |
| 37000-455-03 | 37000045503 | 2 CARTON in 1 CARTON (37000-455-03) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 2 carton | 2003-07-14 | 0000-00-00 | No | No | Current |
| 37000-455-04 | 37000045504 | 3 CARTON in 1 CARTON (37000-455-04) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 3 carton | 2003-07-14 | 0000-00-00 | No | No | Current |
| 37000-455-05 | 37000045505 | 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (37000-455-05) | | 2003-07-14 | 0000-00-00 | No | No | Current |