Prescription drug · ANDA
medroxyprogesterone acetate NDC 70121-1480
Medroxyprogesterone acetate 150 mg/mL · Injection, Suspension · Intramuscular · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70121-1480-1 | 70121148001 | 1 SYRINGE, GLASS in 1 CARTON (70121-1480-1) / 1 mL in 1 SYRINGE, GLASSMarketed from Jun 13, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215397
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 70121-1480_391fd062-e255-4396-aaff-027344c3a39dSPL ID 391fd062-e255-4396-aaff-027344c3a39dSPL set ID 6457d70a-2f25-4935-8511-726d988f7a03RxCUI 1000126, 1000153UNII C2QI4IOI2GUPC 0370121146728, 0370121148012
- 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
N470121148001followed by a unit qualifier and the quantityPackage 70121-1480-01. 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 ye…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215397
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 | REMEDYREPACK INC. | 70518-4324 |
| medroxyprogesterone acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | Amneal Pharmaceuticals LLC | 70121-1467 |