NDC codes

FDA NDC Directory
Product NDC (as listed)67457-887Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67457-0887Add 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 NDC11-digit (billing)PackageCopy
67457-887-01674570887016745708870125 VIAL in 1 CARTON (67457-887-01) / 1 mL in 1 VIAL (67457-887-00)Marketed from Oct 12, 2018
67457-887-9967457088799674570887991 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 LLCNDC labeler code 67457
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.

How CPT relates to drug billing

NDC on a medical claim

N467457088701 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 67457-887

What is NDC 67457-887?
67457-887 is the product NDC for Medroxyprogesterone Acetate, Medroxyprogesterone acetate 150 mg/mL injection, suspension, listed with the FDA by Mylan Institutional LLC. 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?
Mylan Institutional LLC, NDC labeler code 67457. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Medroxyprogesterone AcetateMedroxyprogesterone acetate 2.5 mg/1TabletOralREMEDYREPACK INC.70518-466670518-4666-0070518-4666-02
Medroxyprogesterone AcetateMedroxyprogesterone acetate 150 mg/mLInjection, SuspensionIntramuscularAmneal Pharmaceuticals NY LLC60219-146760219-1467-0160219-1467-02
medroxyprogesterone acetateMedroxyprogesterone acetate 150 mg/mLInjection, SuspensionIntramuscularREMEDYREPACK INC.70518-432470518-4324-00
Medroxyprogesterone AcetateMedroxyprogesterone acetate 2.5 mg/1TabletOralCoupler LLC67046-148067046-1480-03
Medroxyprogesterone AcetateMedroxyprogesterone acetate 150 mg/mLInjection, SuspensionIntramuscularXiromed LLC70700-31570700-0315-2570700-0315-27
Medroxyprogesterone AcetateMedroxyprogesterone acetate 10 mg/1TabletOralNorthwind Health Company, LLC51655-52051655-0520-52
medroxyprogesterone acetateMedroxyprogesterone acetate 150 mg/mLInjection, SuspensionIntramuscularAmneal Pharmaceuticals LLC70121-146770121-1467-0270121-1467-05
medroxyprogesterone acetateMedroxyprogesterone acetate 150 mg/mLInjection, SuspensionIntramuscularAmneal Pharmaceuticals LLC70121-148070121-1480-01
Medroxyprogesterone AcetateMedroxyprogesterone acetate 150 mg/mLInjection, SuspensionIntramuscularEugia US LLC55150-33055150-0330-01
Medroxyprogesterone AcetateMedroxyprogesterone acetate 150 mg/mLInjection, SuspensionIntramuscularEugia US LLC55150-32955150-0329-0155150-0329-25

All 40 Medroxyprogesterone Acetate NDCs

Other NDCs under ANDA 210227

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 210227
ProductStrengthForm · routeLabelerProduct NDC
Medroxyprogesterone AcetateMedroxyprogesterone acetate 150 mg/mLInjection, SuspensionIntramuscularAmneal Pharmaceuticals NY LLC60219-1467
Medroxyprogesterone AcetateMedroxyprogesterone acetate 150 mg/mLInjection, SuspensionIntramuscularXiromed LLC70700-315

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