celecoxib
- Product NDC
- 68180-397
- 11-digit product format
- 681800397
- Labeler code
- 68180
- Product ID
- 68180-397_64af7d57-a662-4efd-8180-26e3023170b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- celecoxib
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA202240
- Marketing category
- ANDA
- Marketing start
- 2015-08-07
- Marketing end
- 2021-09-30
- Substance
- CELECOXIB
- Active strength
- 200 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-397-01 | celecoxib | 100 in 1 BOTTLE | CAPSULE | 100 | | 15 |
| 68180-397-02 | celecoxib | 500 in 1 BOTTLE | CAPSULE | 500 | | 15 |
| 68180-397-03 | celecoxib | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CELECOXIB | ACTIVE INGREDIENT | JCX84Q7J1L | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| CELECOXIB | ACTIVE MOIETY | JCX84Q7J1L | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-397 | CELECOXIB CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 15 | Legacy NDC, 3 package rows | 20231209_560017b1-daf8-464e-b86f-0a75c78002ec.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 |
|---|
| 68180-397-01 | 68180039701 | 100 CAPSULE in 1 BOTTLE (68180-397-01) | 100 capsule | 2016-03-17 | 2021-08-31 | No | No | Current |
| 68180-397-02 | 68180039702 | 500 CAPSULE in 1 BOTTLE (68180-397-02) | 500 capsule | 2015-10-01 | 2021-09-30 | No | No | Current |
| 68180-397-03 | 68180039703 | 1000 in 1 BOTTLE | | | | | | Historical |