leuprolide acetate
- Product NDC
- 0121-2106
- 11-digit product format
- 001212106
- Labeler code
- 0121
- Product ID
- 0121-2106_b1a3e37b-0513-40cc-ab82-a6ec15dc533c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- leuprolide acetate
- Dosage form
- KIT
- Route
- SUBCUTANEOUS
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA217957
- Marketing category
- ANDA
- Marketing start
- 2025-02-01
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- leuprolide acetate
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 545835, 797544 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-1053-02 | leuprolide acetate | 2.8 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2.8 mL | 5 mg in 1mL | 4 |
| 0121-1053-02 | leuprolide acetate | 1 in 1 CARTON | INJECTION, SOLUTION | | 5 mg in 1mL | 4 |
| 0121-2105-01 | leuprolide acetate | 1 mL in 1 PACKET | SWAB | 28 mL | 0.7 mL in 1mL | 4 |
| 0121-2106-02 | leuprolide acetate | 1 in 1 CARTON | KIT | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-2106 | LEUPROLIDE ACETATE KIT [PAI HOLDINGS, LLC DBA PAI PHARMA] | 3 | Current NDC, 4 package rows | 20250201_19be0b7f-e68a-4547-9e49-b51b12821907.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0121-1053-02 | 00121105302 | 2.8 mL in 1 VIAL, MULTI-DOSE | 2.8 ml | | | | Historical |
| 0121-2105-01 | 00121210501 | 1 mL in 1 PACKET | 1 ml | | | | Historical |
| 0121-2106-02 | 00121210602 | 1 KIT in 1 CARTON (0121-2106-02) * 1 VIAL, MULTI-DOSE in 1 CARTON (0121-1053-02) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (0121-2105-01) | 1 kit | 2025-02-01 | No | No | Current |