What is NDC 0548-5400?

0548-5400 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 2 package NDCs, shown above in 10- and 11-digit form.

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.

Medroxyprogesterone Acetate NDC 0548-5400

NDC codes

FDA NDC Directory

Product NDC (as listed)0548-5400Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00548-5400Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0548-5400-00	00548540000	1 VIAL, SINGLE-DOSE in 1 CARTON (0548-5400-00) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 28, 2017
0548-5400-25	00548540025	25 VIAL, SINGLE-DOSE in 1 CARTON (0548-5400-25) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 27, 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 077235
Marketing start: Nov 28, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Progesterone Congeners (Chemical structure)
Identifiers: Product ID 0548-5400_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.

How CPT relates to drug billing

NDC on a medical claim

N400548540000 followed by a unit qualifier and the quantity

Package 00548-5400-00. 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 Jan 1, 2026. 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.

Full label on DailyMed (opens in a new tab)

About NDC 0548-5400

What is NDC 0548-5400?: 0548-5400 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 2 package NDCs, 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Medroxyprogesterone Acetate NDCs
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

All 40 Medroxyprogesterone Acetate NDCs