Megestrol Acetate
- Product NDC
- 0121-0945
- 11-digit product format
- 001210945
- Labeler code
- 0121
- Product ID
- 0121-0945_e4cbdf23-39ea-4f8e-b7b3-139b45d169f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Megestrol Acetate
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC dba PAI Pharma
- Application
- ANDA075671
- Marketing category
- ANDA
- Marketing start
- 2001-07-25
- Substance
- MEGESTROL ACETATE
- Active strength
- 400 mg/10mL
- Pharmacologic classes
- Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Megestrol Acetate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MEGESTROL ACETATE | 400 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TJ2M0FR8ES |
| Rxcui | 860225 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-0945-00 | Megestrol Acetate | 10 in 1 CASE | SUSPENSION | 10 | | 4 |
| 0121-0945-00 | Megestrol Acetate | 10 in 1 TRAY | SUSPENSION | 10 | | 4 |
| 0121-0945-10 | Megestrol Acetate | 10 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 10 | | 4 |
| 0121-0945-40 | Megestrol Acetate | 10 in 1 TRAY | SUSPENSION | 10 | | 4 |
| 0121-0945-40 | Megestrol Acetate | 4 in 1 CASE | SUSPENSION | 4 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-0945 | MEGESTROL ACETATE SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA] | 4 | Current NDC, Legacy NDC, 5 package rows | 20250210_46622697-2c51-44d5-9f1f-e48f8526f132.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 |
|---|
| 0121-0945-00 | 00121094500 | 10 TRAY in 1 CASE (0121-0945-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0945-10) | 10 tray | 2021-10-26 | 0000-00-00 | No | No | Current |
| 0121-0945-10 | 00121094510 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | | | | | Historical |
| 0121-0945-40 | 00121094540 | 4 TRAY in 1 CASE (0121-0945-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0945-10) | 4 tray | 2021-10-26 | 0000-00-00 | No | No | Current |