Hydroxyprogesterone Caproate
- Product NDC
- 55150-311
- 11-digit product format
- 551500311
- Labeler code
- 55150
- Product ID
- 55150-311_b8f27635-ad16-41d2-a667-eaf51437947a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxyprogesterone Caproate
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR
- Labeler
- AuroMedics Pharma LLC
- Application
- ANDA211142
- Marketing category
- ANDA
- Marketing start
- 2019-05-09
- Substance
- HYDROXYPROGESTERONE CAPROATE
- Active strength
- 1250 mg/5mL
- 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
- Hydroxyprogesterone Caproate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYPROGESTERONE CAPROATE | 1250 mg/5mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-311-01 | Hydroxyprogesterone Caproate | 5 mL in 1 VIAL | INJECTION | 5 | | 4 |
| 55150-311-01 | Hydroxyprogesterone Caproate | 1 in 1 CARTON | INJECTION | 1 | | 4 |
| 55150-311-05 | Hydroxyprogesterone Caproate | 5 in 1 CARTON | INJECTION | 5 | | 4 |
| 55150-311-05 | Hydroxyprogesterone Caproate | 5 mL in 1 VIAL | INJECTION | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-311 | HYDROXYPROGESTERONE CAPROATE INJECTION [AUROMEDICS PHARMA LLC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20220626_687bcf42-f437-42c7-8909-a91f621f55df.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 |
|---|
| 55150-311-01 | 55150031101 | 1 VIAL in 1 CARTON (55150-311-01) / 5 mL in 1 VIAL | 1 vial | 2019-05-09 | 0000-00-00 | No | No | Current |
| 55150-311-05 | 55150031105 | 5 VIAL in 1 CARTON (55150-311-05) / 5 mL in 1 VIAL | 5 vial | 2019-05-09 | 0000-00-00 | No | No | Current |