Megestrol Acetate
- Product NDC
- 68094-063
- 11-digit product format
- 680940063
- Labeler code
- 68094
- Product ID
- 68094-063_46a043c6-0099-4723-bbf9-4591a72738fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Megestrol Acetate
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Precision Dose Inc.
- Application
- ANDA075671
- Marketing category
- ANDA
- Marketing start
- 2022-07-11
- Substance
- MEGESTROL ACETATE
- Active strength
- 40 mg/mL
- 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 | 40 mg/mL |
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 |
|---|
| 68094-063-59 | Megestrol Acetate | 10 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 10 | | 2 |
| 68094-063-61 | Megestrol Acetate | 10 in 1 TRAY | SUSPENSION | 10 | | 2 |
| 68094-063-61 | Megestrol Acetate | 10 in 1 CASE | SUSPENSION | 10 | | 2 |
| 68094-063-62 | Megestrol Acetate | 3 in 1 CASE | SUSPENSION | 3 | | 2 |
| 68094-063-62 | Megestrol Acetate | 10 in 1 TRAY | SUSPENSION | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68094-063 | MEGESTROL ACETATE SUSPENSION [PRECISION DOSE INC.] | 2 | Current NDC, Legacy NDC, 5 package rows | 20240404_d0ad931e-4e3e-48bf-9949-77d6971da6e6.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 |
|---|
| 68094-063-59 | 68094006359 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | | | | | Historical |
| 68094-063-61 | 68094006361 | 10 TRAY in 1 CASE (68094-063-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-063-59) | 10 tray | 2022-07-11 | 0000-00-00 | No | No | Current |
| 68094-063-62 | 68094006362 | 3 TRAY in 1 CASE (68094-063-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-063-59) | 3 tray | 2022-07-11 | 0000-00-00 | No | No | Current |