Bleomycin
- Product NDC
- 63323-136
- 11-digit product format
- 633230136
- Labeler code
- 63323
- Product ID
- 63323-136_93aba071-101f-4610-90fa-27e3635b2c1c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BLEOMYCIN SULFATE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA065185
- Marketing category
- ANDA
- Marketing start
- 2009-02-13
- Substance
- BLEOMYCIN SULFATE
- Active strength
- 15 [USP'U]/1
- Pharmacologic classes
- Cytoprotective Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bleomycin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BLEOMYCIN SULFATE | 15 [USP'U]/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7DP3NTV15T |
| Rxcui | 1726673, 1726676 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-136-10 | Bleomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
| 63323-136-10 | Bleomycin | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BLEOMYCIN SULFATE | ACTIVE INGREDIENT | 7DP3NTV15T | BLEOMYCIN (BLEOMYCIN SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 4 | |
| BLEOMYCIN | ACTIVE MOIETY | 40S1VHN69B | BLEOMYCIN (BLEOMYCIN SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-136 | BLEOMYCIN (BLEOMYCIN SULFATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20241013_b5806c40-12ce-48e3-8abd-9f8997ef4428.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 |
|---|
| 63323-136-10 | 63323013610 | 1 VIAL in 1 CARTON (63323-136-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1 vial | 2009-02-13 | 0000-00-00 | No | No | Current |