Prescription drug · ANDA
Hydroxyprogesterone Caproate NDC 55150-311
Hydroxyprogesterone caproate 1250 mg/5mL · Injection · Intramuscular · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-311-01 | 55150031101 | 1 VIAL in 1 CARTON (55150-311-01) / 5 mL in 1 VIALMarketed from May 9, 2019 | |
| 55150-311-05 | 55150031105 | 5 VIAL in 1 CARTON (55150-311-05) / 5 mL in 1 VIALMarketed from May 9, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Hydroxyprogesterone Caproate
- Generic name (nonproprietary)
- hydroxyprogesterone caproate
- Active ingredients
- Hydroxyprogesterone caproate — 1250 mg/5mL
- Dosage form
- Injection
- Route
- Intramuscular
- Labeler
- Eugia US LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211142
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 55150-311_d40b4000-5dae-43fb-8a3b-0dd73e43a806SPL ID d40b4000-5dae-43fb-8a3b-0dd73e43a806SPL set ID 687bcf42-f437-42c7-8909-a91f621f55dfRxCUI 1087964UNII 276F2O42F5
- Pharmacologic class
- Progestin
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N455150031101followed by a unit qualifier and the quantityPackage 55150-0311-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Hydroxyprogesterone Caproate Injection, USP is indicated in non-pregnant women: for the treatment of advanced adenocarcinoma of the uterine corpus (Stage III or IV); in the management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer; as a test for endogenous estrogen production and for the production of secretory endometrium and desquamation.
Excerpt only. Read the full label for complete information.