Epirubicin Hydrochloride
- Product NDC
- 66758-042
- 11-digit product format
- 667580042
- Labeler code
- 66758
- Product ID
- 66758-042_516afd6b-38ec-4819-9bb1-37606c0d6739
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Epirubicin Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sandoz Inc
- Application
- ANDA065339
- Marketing category
- ANDA
- Marketing start
- 2009-12-22
- Marketing end
- 0000-00-00
- Substance
- EPIRUBICIN HYDROCHLORIDE
- Active strength
- 2 mg/mL
- Pharmacologic classes
- Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66758-042-01 | 2020-11-30 | C162847 | 48780-1 | 9855e2a2-48c0-60a7-e053-dbdaa90a05bd | 140e953d-d180-4097-80da-b3ecb50465d5 |
| 66758-042-02 | 2020-11-30 | C162847 | 48780-1 | 9855e2a2-48c0-60a7-e053-dbdaa90a05bd | 140e953d-d180-4097-80da-b3ecb50465d5 |
| 66758-042-01 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-48c0-60a7-e053-dbdaa90a05bd | 140e953d-d180-4097-80da-b3ecb50465d5 |
| 66758-042-02 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-48c0-60a7-e053-dbdaa90a05bd | 140e953d-d180-4097-80da-b3ecb50465d5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66758-042-01 | ML - Milliliter | 66758-042 | dcd35e40-895e-43b0-a3ad-855da620b3eb | 1 | 2012-07-24 |
| 66758-042-02 | ML - Milliliter | 66758-042 | 9a821d5a-8172-46e8-a601-c3d4e4bbeb16 | 1 | 2012-07-24 |