Prescription drug · ANDA
Medroxyprogesterone Acetate NDC 67457-887
Medroxyprogesterone acetate 150 mg/mL · Injection, Suspension · Intramuscular · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-887-01 | 67457088701 | 25 VIAL in 1 CARTON (67457-887-01) / 1 mL in 1 VIAL (67457-887-00)Marketed from Oct 12, 2018 | |
| 67457-887-99 | 67457088799 | 1 VIAL in 1 CARTON (67457-887-99) / 1 mL in 1 VIAL (67457-887-00)Marketed from Oct 12, 2018 |
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)
- Medroxyprogesterone Acetate
- Generic name (nonproprietary)
- medroxyprogesterone acetate
- Active ingredients
- Medroxyprogesterone acetate — 150 mg/mL
- Dosage form
- Injection, Suspension
- Route
- Intramuscular
- Labeler
- Mylan Institutional LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210227
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 67457-887_e991ce3c-100b-2015-f61e-676217681e0fSPL ID e991ce3c-100b-2015-f61e-676217681e0fSPL set ID 60aba812-59eb-4d40-9b6b-d135dca9d36bRxCUI 1000126UNII C2QI4IOI2GUPC 0367457887999
- 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 codeMed-Code curated
J1050 — Injection, medroxyprogesterone acetate, 1 mg
Billing unit: 1 mg. Units on the claim = dose given ÷ 1 mg.
- 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
N467457088701followed by a unit qualifier and the quantityPackage 67457-0887-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use: The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ]. Medroxyprogesterone acetate injectable suspension is a progestin indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Limitations of Use: The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210227
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | Amneal Pharmaceuticals NY LLC | 60219-1467 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | Xiromed LLC | 70700-315 |