Progesterone
- Product NDC
- 50742-359
- 11-digit product format
- 507420359
- Labeler code
- 50742
- Product ID
- 50742-359_2b7a32c4-b3ab-46e3-b3c7-bbb2553b8b3a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Progesterone
- Dosage form
- INSERT
- Route
- VAGINAL
- Labeler
- Ingenus Pharmaceuticals, LLC
- Application
- ANDA219588
- Marketing category
- ANDA
- Marketing start
- 2026-10-16
- 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
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Progesterone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROGESTERONE | 100 mg/1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50742-359-21 | 50742035921 | 1 CARTON in 1 CARTON (50742-359-21) / 21 BLISTER PACK in 1 CARTON (50742-359-07) / 1 INSERT in 1 BLISTER PACK (50742-359-03) | 1 carton | 2026-10-16 | No | No | Current |