CITALOPRAM HYDROBROMIDE
- Product NDC
- 76282-629
- 11-digit product format
- 762820629
- Labeler code
- 76282
- Product ID
- 76282-629_fd69f24e-8108-4b9e-92ca-13ebbdf86e45
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CITALOPRAM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals Inc.
- Application
- ANDA077534
- Marketing category
- ANDA
- Marketing start
- 2017-11-10
- Substance
- CITALOPRAM HYDROBROMIDE
- Active strength
- 20 mg/1
- 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 HYDROBROMIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CITALOPRAM HYDROBROMIDE | 20 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | I1E9D14F36 |
| Rxcui | 200371, 283672, 309314 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 475812f9-1b2c-4cb0-9e72-1e52f935ae6f | Product name | 1 | 20221114 |
| 0b05d650-9b7b-4b36-a6f4-1a850d5a2e64 | Product name | 1 | 20151228 |
| e61ea6cb-0b08-40a9-a984-7b23201c7aa2 | Product name | 1 | 20151222 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76282-629-05 | CITALOPRAM HYDROBROMIDE | 500 in 1 BOTTLE | TABLET | 500 | 15 | |
| 76282-629-10 | CITALOPRAM HYDROBROMIDE | 1000 in 1 BOTTLE | TABLET | 1000 | 15 | |
| 76282-629-30 | CITALOPRAM HYDROBROMIDE | 30 in 1 BOTTLE | TABLET | 30 | 15 | |
| 76282-629-90 | CITALOPRAM HYDROBROMIDE | 90 in 1 BOTTLE | TABLET | 90 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 76282-629-10 | EA - Each | 76282-629 | a9aae282-7e73-442a-8455-9491a480300a | 1 | 2018-06-11 |
| 76282-629-90 | EA - Each | 76282-629 | 5c5c9261-cfca-4ecd-a2ea-3aaec5e8388a | 1 | 2024-04-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CITALOPRAM HYDROBROMIDE | ACTIVE INGREDIENT | I1E9D14F36 | CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.] | 2 | |
| CITALOPRAM | ACTIVE MOIETY | 0DHU5B8D6V | CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.] | 2 | |
| COPOVIDONE | INACTIVE INGREDIENT | D9C330MD8B | CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CITALOPRAM HYDROBROMIDE (CITALOPRAM ) TABLET [EXELAN PHARMACEUTICALS INC.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 283672 | citalopram 10 MG Oral Tablet | PSN | a8e8fde2-8392-4d5b-902b-e2b9dd55a02d | 15 |
| 200371 | citalopram 20 MG Oral Tablet | PSN | a8e8fde2-8392-4d5b-902b-e2b9dd55a02d | 15 |
| 309314 | citalopram 40 MG Oral Tablet | PSN | a8e8fde2-8392-4d5b-902b-e2b9dd55a02d | 15 |
| 283672 | citalopram 10 MG Oral Tablet | SCD | a8e8fde2-8392-4d5b-902b-e2b9dd55a02d | 15 |
| 200371 | citalopram 20 MG Oral Tablet | SCD | a8e8fde2-8392-4d5b-902b-e2b9dd55a02d | 15 |
| 309314 | citalopram 40 MG Oral Tablet | SCD | a8e8fde2-8392-4d5b-902b-e2b9dd55a02d | 15 |
| 283672 | citalopram 10 MG (as citalopram HBr 12.49 MG) Oral Tablet | SY | a8e8fde2-8392-4d5b-902b-e2b9dd55a02d | 15 |
| 200371 | citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet | SY | a8e8fde2-8392-4d5b-902b-e2b9dd55a02d | 15 |
| 309314 | citalopram 40 MG (as citalopram HBr 49.98 MG) Oral Tablet | SY | a8e8fde2-8392-4d5b-902b-e2b9dd55a02d | 15 |
| 200371 | citalopram 20 MG Oral Tablet | PSN | d05f4e71-95f3-4f22-8b01-b21e5c19e0f2 | 1 |
| 200371 | citalopram 20 MG Oral Tablet | SCD | d05f4e71-95f3-4f22-8b01-b21e5c19e0f2 | 1 |
| 200371 | citalopram 20 MG (as citalopram HBr 24.99 MG) Oral Tablet | SY | d05f4e71-95f3-4f22-8b01-b21e5c19e0f2 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 76282-629-05 | 76282062905 | 500 TABLET in 1 BOTTLE (76282-629-05) | 500 tablet | 2017-11-10 | 0000-00-00 | No | No | Current |
| 76282-629-10 | 76282062910 | 1000 TABLET in 1 BOTTLE (76282-629-10) | 1000 tablet | 2017-11-10 | 0000-00-00 | No | No | Current |
| 76282-629-30 | 76282062930 | 30 TABLET in 1 BOTTLE (76282-629-30) | 30 tablet | 2017-11-10 | 0000-00-00 | No | No | Current |
| 76282-629-90 | 76282062990 | 90 TABLET in 1 BOTTLE (76282-629-90) | 90 tablet | 2017-11-10 | 0000-00-00 | No | No | Current |