Prescription drug · ANDA
Medroxyprogesterone Acetate NDC 0548-5701
Medroxyprogesterone acetate 150 mg/mL · Injection, Suspension, Extended release · Intramuscular · Amphastar Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0548-5701-00 | 00548570100 | 1 SYRINGE in 1 CARTON (0548-5701-00) / 1 mL in 1 SYRINGEMarketed from Nov 28, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Extended release
- Route
- Intramuscular
- Labeler
- Amphastar Pharmaceuticals, Inc.NDC labeler code 0548
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077334
- Marketing start
- Listing expires
- Other FDA classes
- Progesterone Congeners (Chemical structure)
- Identifiers
- Product ID 0548-5701_8ef1da8b-5fce-4375-9186-39f75adc4f1bSPL ID 8ef1da8b-5fce-4375-9186-39f75adc4f1bSPL set ID fda1aa8a-5739-482a-b4f6-9741ef4d9977RxCUI 1000126, 1000153UNII C2QI4IOI2G
- 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
N400548570100followed by a unit qualifier and the quantityPackage 00548-5701-00. 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 is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use: The use of Medroxyprogesterone acetate 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 is a progestin indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Limitations of Use: The use of Medroxyprogesterone acetate is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. ( 1 , 5…
Excerpt only. Read the full label for complete information.
About NDC 0548-5701
- What is NDC 0548-5701?
- 0548-5701 is the product NDC for Medroxyprogesterone Acetate, Medroxyprogesterone acetate 150 mg/mL injection, suspension, extended release, listed with the FDA by Amphastar Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Medroxyprogesterone Acetate.
- What is the active ingredient?
- Medroxyprogesterone acetate.
- Who is the labeler?
- Amphastar Pharmaceuticals, Inc., NDC labeler code 0548. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Medroxyprogesterone Acetate?
- 39 other product NDCs are listed under this name. See all Medroxyprogesterone Acetate NDCs.
- Is there a related HCPCS / J-code?
- Yes: J1050, Injection, medroxyprogesterone acetate, 1 mg. See Billing references above.
Related NDCs: other Medroxyprogesterone Acetate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 2.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4666 | 70518-4666-0070518-4666-02 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | Amneal Pharmaceuticals NY LLC | 60219-1467 | 60219-1467-0160219-1467-02 |
| medroxyprogesterone acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | REMEDYREPACK INC. | 70518-4324 | 70518-4324-00 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1480 | 67046-1480-03 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | Xiromed LLC | 70700-315 | 70700-0315-2570700-0315-27 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-520 | 51655-0520-52 |
| medroxyprogesterone acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | Amneal Pharmaceuticals LLC | 70121-1467 | 70121-1467-0270121-1467-05 |
| medroxyprogesterone acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | Amneal Pharmaceuticals LLC | 70121-1480 | 70121-1480-01 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | Eugia US LLC | 55150-330 | 55150-0330-01 |
| Medroxyprogesterone Acetate | Medroxyprogesterone acetate 150 mg/mL | Injection, SuspensionIntramuscular | Eugia US LLC | 55150-329 | 55150-0329-0155150-0329-25 |