Citalopram
- Product NDC
- 0054-0062
- 11-digit product format
- 000540062
- Labeler code
- 0054
- Product ID
- 0054-0062_6a701183-6c4f-448f-a05a-81ee7f5b734f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Citalopram
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA077043
- Marketing category
- ANDA
- Marketing start
- 2004-05-25
- Substance
- CITALOPRAM HYDROBROMIDE
- Active strength
- 10 mg/5mL
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake 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
- Citalopram
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CITALOPRAM HYDROBROMIDE | 10 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I1E9D14F36 |
| Rxcui | 309313 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0062-58 | Citalopram | 1 in 1 CARTON | SOLUTION | 1 | | 23 |
| 0054-0062-58 | Citalopram | 240 mL in 1 BOTTLE, PLASTIC | SOLUTION | 240 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CITALOPRAM HYDROBROMIDE | ACTIVE INGREDIENT | I1E9D14F36 | CITALOPRAM SOLUTION [ROXANE LABORATORIES, INC] | 11 | |
| CITALOPRAM | ACTIVE MOIETY | 0DHU5B8D6V | CITALOPRAM SOLUTION [ROXANE LABORATORIES, INC] | 11 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | CITALOPRAM SOLUTION [ROXANE LABORATORIES, INC] | 11 | |
| PEPPERMINT | INACTIVE INGREDIENT | V95R5KMY2B | CITALOPRAM SOLUTION [ROXANE LABORATORIES, INC] | 11 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CITALOPRAM SOLUTION [ROXANE LABORATORIES, INC] | 11 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | CITALOPRAM SOLUTION [ROXANE LABORATORIES, INC] | 11 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | CITALOPRAM SOLUTION [ROXANE LABORATORIES, INC] | 11 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CITALOPRAM SOLUTION [ROXANE LABORATORIES, INC] | 11 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0062 | CITALOPRAM SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 23 | Current NDC, Legacy NDC, 2 package rows | 20230812_29408d84-7b00-4cee-969c-8095f8083ff5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0062-58 | 00054006258 | 1 BOTTLE, PLASTIC in 1 CARTON (0054-0062-58) / 240 mL in 1 BOTTLE, PLASTIC | 2004-05-25 | 0000-00-00 | No | No | Current |