Pulmotech MAA
- Product NDC
- 69945-139
- 11-digit product format
- 699450139
- Labeler code
- 69945
- Product ID
- 69945-139_702e29eb-f585-45b4-93ff-4d83e2788513
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- kit for the preparation of technetium Tc 99m albumin aggregated
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
- Route
- INTRAPERITONEAL; INTRAVENOUS
- Labeler
- Curium US LLC
- Application
- BLA210089
- Marketing category
- BLA
- Marketing start
- 2020-03-20
- Substance
- ALBUMIN AGGREGATED
- Active strength
- 2 mg/15mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pulmotech MAA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALBUMIN AGGREGATED | 2 mg/15mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 799C8VF17R |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69945-139-10 | Pulmotech MAA | 15 mL in 1 VIAL, MULTI-DOSE | INJECTION, POWDER, LYOPHILIZED, | 15 | | 26 |
| 69945-139-20 | Pulmotech MAA | 5 in 1 CELLO PACK | INJECTION, POWDER, LYOPHILIZED, | 5 | | 26 |
| 69945-139-40 | Pulmotech MAA | 30 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 30 | | 26 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69945-139 | PULMOTECH MAA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED) INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION [CURIUM US LLC] | 23 | Current NDC, Legacy NDC, 3 package rows | 20230831_a8b7adf0-2c6b-4acd-96d3-a099306951a0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69945-139-10 | 69945013910 | 15 mL in 1 VIAL, MULTI-DOSE | 15 ml | | | | | Historical |
| 69945-139-20 | 69945013920 | 5 VIAL, MULTI-DOSE in 1 CELLO PACK (69945-139-20) / 15 mL in 1 VIAL, MULTI-DOSE (69945-139-10) | | 2020-03-20 | 0000-00-00 | No | No | Current |
| 69945-139-40 | 69945013940 | 30 VIAL, MULTI-DOSE in 1 CARTON (69945-139-40) / 15 mL in 1 VIAL, MULTI-DOSE (69945-139-10) | | 2020-03-20 | 0000-00-00 | No | No | Current |