Omeprazole
- Product NDC
- 33261-117
- 11-digit product format
- 332610117
- Labeler code
- 33261
- Product ID
- 33261-117_884283f6-ff17-45e2-8452-731609251271
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA075576
- Marketing category
- ANDA
- Marketing start
- 2009-01-21
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 33261-117-02 | Omeprazole | 120 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 120 | | 1 |
| 33261-117-06 | Omeprazole | 6 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 6 | | 1 |
| 33261-117-10 | Omeprazole | 10 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 10 | | 1 |
| 33261-117-20 | Omeprazole | 20 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 20 | | 1 |
| 33261-117-30 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 1 |
| 33261-117-60 | Omeprazole | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 1 |
| 33261-117-90 | Omeprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| OMEPRAZOLE | ACTIVE INGREDIENT | KG60484QX9 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| OMEPRAZOLE | ACTIVE MOIETY | KG60484QX9 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MEGLUMINE | INACTIVE INGREDIENT | 6HG8UB2MUY | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLOXAMER 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33261-117 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 7 package rows | 20121007_9a77cf66-e110-4d51-ae8a-bea6207bba75.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 33261-117-02 | 33261011702 | 120 in 1 BOTTLE | Historical |
| 33261-117-06 | 33261011706 | 6 in 1 BOTTLE | Historical |
| 33261-117-10 | 33261011710 | 10 in 1 BOTTLE | Historical |
| 33261-117-20 | 33261011720 | 20 in 1 BOTTLE | Historical |
| 33261-117-30 | 33261011730 | 30 in 1 BOTTLE | Historical |
| 33261-117-60 | 33261011760 | 60 in 1 BOTTLE | Historical |
| 33261-117-90 | 33261011790 | 90 in 1 BOTTLE | Historical |