PROGESTERONE VAGINAL INSERTS
- Product NDC
- 68462-175
- 11-digit product format
- 684620175
- Labeler code
- 68462
- Product ID
- 68462-175_41682665-e889-4e2a-9382-88f6bcc30237
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- progesterone
- Dosage form
- INSERT
- Route
- VAGINAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA216363
- Marketing category
- ANDA
- Marketing start
- 2026-04-08
- Substance
- PROGESTERONE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Progesterone [CS], Progesterone [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PROGESTERONE VAGINAL INSERTS
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROGESTERONE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4G7DS2Q64Y |
| Rxcui | 725094 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68462-175-33 | PROGESTERONE VAGINAL INSERTS | 21 in 1 CARTON | INSERT | 21 | | 1 |
| 68462-175-40 | PROGESTERONE VAGINAL INSERTS | 1 in 1 BLISTER PACK | INSERT | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68462-175-33 | 68462017533 | 21 BLISTER PACK in 1 CARTON (68462-175-33) / 1 INSERT in 1 BLISTER PACK (68462-175-40) | 21 blister pack | 2026-04-08 | No | No | Current |
| 68462-175-40 | 68462017540 | 1 in 1 BLISTER PACK | | | | | Historical |