Irinotecan hydrochloride
- Product NDC
- 45963-614
- 11-digit product format
- 459630614
- Labeler code
- 45963
- Product ID
- 45963-614_3bbdb61c-9194-416e-9034-5d2b11b5b8ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irinotecan hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA078589
- Marketing category
- ANDA
- Marketing start
- 2015-03-12
- Marketing end
- 2027-09-30
- Substance
- IRINOTECAN HYDROCHLORIDE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Irinotecan hydrochloride
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IRINOTECAN HYDROCHLORIDE | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 042LAQ1IIS |
| Rxcui | 1726319, 1726324 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45963-614-51 | Irinotecan hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 27 |
| 45963-614-51 | Irinotecan hydrochloride | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 27 |
| 45963-614-55 | Irinotecan hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 27 |
| 45963-614-55 | Irinotecan hydrochloride | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 27 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IRINOTECAN HYDROCHLORIDE | ACTIVE INGREDIENT | 042LAQ1IIS | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 9 | |
| IRINOTECAN | ACTIVE MOIETY | 7673326042 | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 9 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 9 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 9 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 9 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45963-614 | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 25 | Current NDC, Legacy NDC, 4 package rows | 20230610_5e1fdcaa-918f-4cd8-9c7a-4c538d866198.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45963-614-51 | 45963061451 | 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-51) / 2 mL in 1 VIAL, SINGLE-DOSE | 2015-03-12 | 2027-09-30 | No | No | Current |
| 45963-614-55 | 45963061455 | 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-55) / 5 mL in 1 VIAL, SINGLE-DOSE | 2015-03-12 | 2027-09-30 | No | No | Current |
| 45963-614-81 | 45963061481 | 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-81) > 2 mL in 1 VIAL, SINGLE-DOSE | 2019-01-17 | 0000-00-00 | No | No | Current |
| 45963-614-85 | 45963061485 | 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-85) > 5 mL in 1 VIAL, SINGLE-DOSE | 2018-08-10 | 0000-00-00 | No | No | Current |