Loratadine
- Product NDC
- 70934-467
- 11-digit product format
- 709340467
- Labeler code
- 70934
- Product ID
- 70934-467_a140ae93-1978-1f8c-e053-2995a90a5e54
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Application
- ANDA076301
- Marketing category
- ANDA
- Marketing start
- 2019-11-26
- Marketing end
- 0000-00-00
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 70934-467-30 | 2023-01-30 | C162847 | 48780-1 | d6a99b39-d4aa-a426-e053-dadaa90af4c2 | 990aaf50-9fa2-12de-e053-2a95a90a939e |
| 70934-467-90 | 2023-01-30 | C162847 | 48780-1 | d6a99b39-d4aa-a426-e053-dadaa90af4c2 | 990aaf50-9fa2-12de-e053-2a95a90a939e |
| 70934-467-97 | 2023-01-30 | C162847 | 48780-1 | d6a99b39-d4aa-a426-e053-dadaa90af4c2 | 990aaf50-9fa2-12de-e053-2a95a90a939e |
| 70934-467-30 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-d4aa-a426-e053-dadaa90af4c2 | 990aaf50-9fa2-12de-e053-2a95a90a939e |
| 70934-467-90 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-d4aa-a426-e053-dadaa90af4c2 | 990aaf50-9fa2-12de-e053-2a95a90a939e |
| 70934-467-97 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-d4aa-a426-e053-dadaa90af4c2 | 990aaf50-9fa2-12de-e053-2a95a90a939e |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70934-467-30 | EA - Each | 70934-467 | 1c7d26dd-6b6a-4c1c-a3f4-612cd7d98a9c | 1 | 2022-12-07 |
| 70934-467-90 | EA - Each | 70934-467 | ad9a3614-a8bd-458e-8513-0edf976837b6 | 1 | 2022-12-07 |
| 70934-467-97 | EA - Each | 70934-467 | 7c69c8fa-3d82-425f-ba65-dede47223f97 | 1 | 2022-12-07 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70934-467-30 | 70934046730 | 30 TABLET in 1 BOTTLE, PLASTIC (70934-467-30) | 30 tablet | 2020-01-06 | 0000-00-00 | No | No | Current |
| 70934-467-90 | 70934046790 | 90 TABLET in 1 BOTTLE, PLASTIC (70934-467-90) | 90 tablet | 2019-11-26 | 0000-00-00 | No | No | Current |
| 70934-467-97 | 70934046797 | 100 TABLET in 1 BOTTLE, PLASTIC (70934-467-97) | 100 tablet | 2020-03-19 | 0000-00-00 | No | No | Current |