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Leuprolide acetate 5 MG/ML Injectable Solution — RxCUI 545835

RxNorm drug concept · Semantic clinical drug
RxCUI 545835 Semantic clinical drug · SCD ● Current RxNorm concept 12 FDA products 12 package NDCs Snapshot Jul 14, 2026

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Compiled from public NLM RxNorm and FDA (openFDA NDC directory) data sources. Editorial policy

What you’re looking at: the standardized identity of one medicine, as the U.S. drug-data system sees it. Below — every FDA-listed product, package code, price benchmark, and billing code that maps to it.

🗂️ Key Facts

RxCUI545835
Official nameLeuprolide acetate 5 MG/ML Injectable Solution
Concept typeSemantic clinical drug (SCD)
RxNorm statusCurrent RxNorm concept
Also known asleuprolide acetate 1 MG per 0.2 ML Injectable Solution; leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution
FDA products mapped12
Package NDCs mapped12
Reported Medicaid activity (SDUD)105 prescriptions · 1 state & territory Medicaid programs · latest period Q4 2025
RxNorm release07/06/2026
Snapshot dataJul 14, 2026

📖 Skip the Codes — Read It in Plain English.

Our pharmacist-built guide to Leuprolide Injection: what it is, how it’s used, side effects, and interactions.

📗 Our plain-language guide HelloPharmacist
  • It depends on the product prescribed. Fensolvi is used for children 2 and older who are going through puberty too early — a condition called central precocious puberty. Products li...
  • What exactly is leuprolide injection used for?
  • This is called a tumor flare, and it's actually expected. In the first one to two weeks, testosterone levels temporarily rise before the medication brings them down. For men with p...
  • Why might symptoms get worse right after starting the injection?
📖 Read our full Leuprolide Injection guide →

🕸️ Concept Web — How Leuprolide acetate 5 MG/ML Injectable Solution Connects

One RxCUI never lives alone. Follow the path from the raw ingredient down to the exact strength-and-form concepts FDA products carry — every stop is a real RxNorm concept with its own identifier. Hover or focus any chip for what it means.
This page's concept Leuprolide acetate 5 MG/ML Injectable Solution RxCUI 545835

Every web starts here: one RxCUI, one fixed meaning in the RxNorm vocabulary.

  1. Ingredients 2

    The active substance itself — no strength, form, or brand attached yet.

    • Leuprolide 42375
    • Leuprolide acetate 203217
  2. Dose forms 6

    The ingredient poured into a form — tablet, solution, cream — still without one fixed strength.

    • Leuprolide Injectable Solution 372576
    • Leuprolide acetate Injectable Solution 2645311
    • Leuprolide Injectable Product 1163443
    • Leuprolide acetate Injectable Product 2659197
    • Injectable Solution 316949
    • Injectable Product 1151126
  3. Clinical & branded drugs 1

    Ingredient + strength + dose form. These are the concepts real FDA products actually carry.

    • Leuprolide acetate 5 MG/ML 545834

Showing up to 8 concepts per family — 9 of 9 stored related concepts drawn.
These are official RxNorm vocabulary relationships — how concepts name and organize the same medicine. They do not establish therapeutic equivalence or substitutability: two concepts appearing in one web is never a statement that products can be swapped.

🔀 Generic ⇄ Brand Crosswalk

The same medicine has an unbranded (generic) identity and one or more brand-name identities — each with its own RxCUI. This is a naming relationship in RxNorm, not a statement that any two products are substitutable.

Generic (Clinical) Concepts

  • Leuprolide acetate 5 MG/ML SCDC · 545834
  • Leuprolide Injectable Solution SCDF · 372576
  • Leuprolide acetate Injectable Solution SCDFP · 2645311
  • Leuprolide Injectable Product SCDG · 1163443
  • Leuprolide acetate Injectable Product SCDGP · 2659197

📦 FDA Products & Package NDCs

12 products · 12 package NDCs
12 package NDCs map to RxCUI 545835 in the current snapshot — up to 50 per page. Each linked NDC opens its full package page.
Package NDC Package Brand / generic name Labeler Marketing start
00121-2106-02 1 KIT in 1 CARTON (0121-2106-02) * 1 VIAL, MULTI-DOSE in 1... leuprolide acetate PAI Holdings, LLC dba PAI Pharma 2025-02-01
00781-4003-32 1 KIT in 1 CARTON (0781-4003-32) * 1 VIAL, MULTI-DOSE in 1... Leuprolide Acetate Sandoz Inc 1998-08-04
42023-0259-00 1 CARTON in 1 KIT (42023-259-00) / 1 VIAL, MULTI-DOSE in 1... LEUPROLIDE ACETATE Endo USA, Inc. 2026-06-30
47335-0936-40 1 KIT in 1 CARTON (47335-936-40) * 1 VIAL, MULTI-DOSE in 1... leuprolide acetate Sun Pharmaceutical Industries, Inc. 2014-12-15
55150-0478-01 1 KIT in 1 CARTON (55150-478-01) * 1 VIAL, MULTI-DOSE in 1... LEUPROLIDE ACETATE Eugia US LLC 2022-06-06
70121-2537-06 1 KIT in 1 CARTON (70121-2537-6) * 1 VIAL, MULTI-DOSE in 1... leuprolide acetate Amneal Pharmaceuticals LLC 2022-11-07
70710-1769-03 1 KIT in 1 CARTON (70710-1769-3) * 1 VIAL, MULTI-DOSE in 1... LEUPROLIDE ACETATE Zydus Pharmaceuticals USA Inc. 2026-01-08
70771-1687-03 1 KIT in 1 CARTON (70771-1687-3) * 1 VIAL, MULTI-DOSE in 1... LEUPROLIDE ACETATE Zydus Lifesciences Limited 2026-01-08
71288-0569-90 1 KIT in 1 CARTON (71288-569-90) * 1 VIAL, MULTI-DOSE in 1... Leuprolide Acetate Meitheal Pharmaceuticals Inc 2024-05-15
72603-0344-01 1 KIT in 1 CARTON (72603-344-01) * 1 VIAL, MULTI-DOSE in 1... Leuprolide Acetate NorthStar RxLLC 2024-03-01
72664-0611-28 1 KIT in 1 CARTON (72664-611-28) * 2.8 mL in 1 VIAL, MULTI... Leuprolide Acetate VGYAAN Pharmaceuticals LLC 2020-10-25
72843-0591-99 1 KIT in 1 CARTON (72843-591-99) * 1 VIAL, MULTI-DOSE in 1... leuprolide acetate UBI Pharma Inc. 2024-10-25
Observed labelers: Amneal Pharmaceuticals LLC (1) · Endo USA, Inc. (1) · Eugia US LLC (1) · Meitheal Pharmaceuticals Inc (1) · NorthStar RxLLC (1) · PAI Holdings, LLC dba PAI Pharma (1) · +6 more — this is the FDA-listed mapping footprint, not sales, inventory, availability, or market share.

🗃️ Sources & Limits

Atlas generation902fddb9-e9c1-4004-bf4c-dba4d51037c7
openFDA export observedJul 14, 2026
RxNorm release07/06/2026
Methodology2026-07-full-catalog-v1
  • A shared RxCUI does not prove interchangeability. Products mapped to the same concept are not thereby equivalent or substitutable — equivalence is a separate, product-level determination.
  • Listing here does not establish approval or coverage. Appearing in this snapshot is a data observation, not an FDA approval status or a payer coverage decision.
  • Missing data never means zero. A silent dataset (no price, no billing code, no utilization) means no observation — not that the real-world value is zero.
  • Counts describe the mapping footprint. Product, package, and labeler counts are the FDA-listed mapping footprint in this snapshot — not sales, inventory, availability, or market share.
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.

Machine-readable JSON

Reference information about drug-concept identifiers and public regulatory data — not medical advice. Talk to your pharmacist or prescriber about your own medication.