Citalopram
- Product NDC
- 70518-2601
- 11-digit product format
- 705182601
- Labeler code
- 70518
- Product ID
- 70518-2601_4a69e716-1140-5ce8-e063-6394a90a57eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- citalopram
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077042
- Marketing category
- ANDA
- Marketing start
- 2020-02-26
- Substance
- CITALOPRAM HYDROBROMIDE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Citalopram
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CITALOPRAM HYDROBROMIDE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I1E9D14F36 |
| Rxcui | 309314 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 70518-2601-0 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-ca6b-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998 |
| 70518-2601-0 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-ca6b-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998 |
| 70518-2601-1 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-ca6b-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998 |
| 70518-2601-1 | 2022-01-31 | C162847 | 48780-1 | d6a99b39-ca6b-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998 |
| 70518-2601-0 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ca6b-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998 |
| 70518-2601-0 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ca6b-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998 |
| 70518-2601-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ca6b-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998 |
| 70518-2601-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ca6b-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use CITALOPRAM TABLETS safely and effectively. See full prescribing information for CITALOPRAM TABLETS . CITALOPRAM tablets, for oral use Initial U.S. Approval: 1998 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-2601-0 | Citalopram | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 14 |
| 70518-2601-1 | Citalopram | 100 in 1 BOX | TABLET, FILM COATED | 100 | | 14 |
| 70518-2601-2 | Citalopram | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 14 |
| 70518-2601-3 | Citalopram | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-2601 | CITALOPRAM TABLET, FILM COATED [REMEDYREPACK INC.] | 11 | Current NDC, Legacy NDC, 4 package rows | 20250322_aa9c1440-354f-43a6-9e70-fd7bafcb03c5.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 |
|---|
| 70518-2601-0 | 70518260100 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2601-0) | | 2020-02-26 | 0000-00-00 | No | No | Current |
| 70518-2601-1 | 70518260101 | 100 POUCH in 1 BOX (70518-2601-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-2601-2) | 100 pouch | 2020-04-16 | 0000-00-00 | No | No | Current |
| 70518-2601-2 | 70518260102 | 1 in 1 POUCH | | | | | | Historical |
| 70518-2601-3 | 70518260103 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2601-3) | | 2024-04-16 | | No | No | Historical |