Tyblume
- Product NDC
- 0642-7471
- 11-digit product format
- 006427471
- Labeler code
- 0642
- Product ID
- 0642-7471_f48a4726-8731-6fcb-e053-2995a90a6bea
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- Exeltis USA, Inc.
- Application
- NDA209405
- Marketing category
- NDA
- Marketing start
- 2020-10-26
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tyblume
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 242297, 2465331, 2539224, 2539227, 2539228 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0642-7471 | TYBLUME (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [EXELTIS USA, INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20230214_b2482d51-d606-4aaa-8af4-19e4fe2f8872.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 |
|---|
| 0642-7471-01 | 00642747101 | 1 BLISTER PACK in 1 BOX (0642-7471-01) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2020-10-26 | 0000-00-00 | No | No | Current |
| 0642-7471-02 | 00642747102 | 1 BLISTER PACK in 1 BOX (0642-7471-02) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2020-10-26 | | Yes | No | Historical |
| 0642-7471-03 | 00642747103 | 3 BLISTER PACK in 1 BOX (0642-7471-03) > 1 KIT in 1 BLISTER PACK | 3 blister pack | 2020-10-26 | 0000-00-00 | No | No | Current |
| 0642-7471-06 | 00642747106 | 6 BLISTER PACK in 1 BOX (0642-7471-06) > 1 KIT in 1 BLISTER PACK | 6 blister pack | 2020-10-26 | 0000-00-00 | No | No | Current |