TopCare Omeprazole
- Product NDC
- 36800-915
- 11-digit product format
- 368000915
- Labeler code
- 36800
- Product ID
- 36800-915_e1557259-5889-4677-981e-ebd3970162c8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- NDA022032
- Marketing category
- NDA
- Marketing start
- 2008-02-29
- Substance
- OMEPRAZOLE
- Active strength
- 20 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
- TopCare Omeprazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEPRAZOLE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG60484QX9 |
| Rxcui | 402014 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-915-01 | TopCare Omeprazole | 1 in 1 CARTON | TABLET, DELAYED RELEASE | 1 | | 8 |
| 36800-915-01 | TopCare Omeprazole | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | | 8 |
| 36800-915-03 | TopCare Omeprazole | 3 in 1 CARTON | TABLET, DELAYED RELEASE | 3 | | 8 |
| 36800-915-03 | TopCare Omeprazole | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | | 8 |
| 36800-915-30 | TopCare Omeprazole | 14 in 1 CARTON | TABLET, DELAYED RELEASE | 14 | | 8 |
| 36800-915-30 | TopCare Omeprazole | 2 in 1 CARTON | TABLET, DELAYED RELEASE | 2 | | 8 |
| 36800-915-55 | TopCare Omeprazole | 3 in 1 CARTON | TABLET, DELAYED RELEASE | 3 | | 8 |
| 36800-915-55 | TopCare Omeprazole | 14 in 1 CARTON | TABLET, DELAYED RELEASE | 14 | | 8 |
| 36800-915-74 | TopCare Omeprazole | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | | 8 |
| 36800-915-74 | TopCare Omeprazole | 14 in 1 CARTON | TABLET, DELAYED RELEASE | 14 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OMEPRAZOLE | ACTIVE INGREDIENT | KG60484QX9 | TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | |
| OMEPRAZOLE | ACTIVE MOIETY | KG60484QX9 | TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | |
| MONOETHANOLAMINE | INACTIVE INGREDIENT | 5KV86114PT | TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | |
| SODIUM STEARATE | INACTIVE INGREDIENT | QU7E2XA9TG | TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-915 | TOPCARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [TOPCO ASSOCIATES LLC] | 8 | Current NDC, Legacy NDC, 10 package rows | 20250112_4d98665d-38db-4c08-8406-cc0e45f7ab7c.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 |
|---|
| 36800-915-01 | 36800091501 | 1 BOTTLE in 1 CARTON (36800-915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2010-10-11 | 0000-00-00 | No | No | Current |
| 36800-915-03 | 36800091503 | 3 BOTTLE in 1 CARTON (36800-915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2011-12-28 | 0000-00-00 | No | No | Current |
| 36800-915-30 | 36800091530 | 2 CARTON in 1 CARTON (36800-915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 2 carton | 2008-02-29 | 0000-00-00 | No | No | Current |
| 36800-915-55 | 36800091555 | 3 CARTON in 1 CARTON (36800-915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 3 carton | 2008-02-29 | 0000-00-00 | No | No | Current |
| 36800-915-74 | 36800091574 | 14 BLISTER PACK in 1 CARTON (36800-915-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK | 14 blister pack | 2008-02-29 | 0000-00-00 | No | No | Current |