Albuterol HFA Inhaler Substitution Refresh

There have been many new albuterol HFA NDCs released since the June 2020 article, First AB-Rated Generic for Proventil® HFA Approved, and since albuterol inhaler substitutions require an extra level of consideration due to not all NDCs being equivalent, a refreshed chart was in order.

The chart below shows albuterol products grouped into their respective Therapeutic Equivalence (TE) Code category – AB1, AB2, or BX. As a reminder, substitution can occur at the pharmacy level if the substitution involves two therapeutically equivalent products and is allowed per state law.

Example: AB1 inhaler 6.7 gm Proventil® would be able to be substituted for AB1 inhaler 6.7 gm Sandoz albuterol HFA. 

If a substitution to a non-equivalent is required, it would be necessary to contact the prescriber and make a corresponding clinical note documenting the conversation.

Example: Prescription written for AB1 inhaler 6.7 gm Proventil® but PBM rejects claim stating an AB2 inhaler such as 8.5 gm Lupin Pharmaceuticals albuterol HFA is required. 

Refer to the article linked above for examples of how to handle substitutions based on how a prescription is written.

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Product NDC Labeler Package Size FDA Application Number Brand or Generic TE Code
Proventil® HFA 66758-0959-85 Sandoz 6.7 gm N020503 Brand AB1
Albuterol sulfate HFA 00054-0742-87 Hikma Pharm. A207085 ANDA Generic
Albuterol sulfate HFA 00781-7296-85 Sandoz N020503 NDA Authorized Generic
Albuterol sulfate HFA 69097-0142-60 Cipla A209959 Generic
Albuterol sulfate HFA 72572-0014-01 Civica A209959 Generic
Albuterol sulfate HFA 76282-0679-42 Exelan Pharm. A209959 Generic
ProAir® HFA 59310-0579-22 Teva Resp. 8.5 gm N021457 Inactive; manufacturing ceased Oct. 2022 AB2
Albuterol sulfate HFA 00093-3174-31 Teva Pharm. N021457 NDA Authorized Generic
Albuterol sulfate HFA 45802-0088-01 Padagis A203760 Generic
Albuterol sulfate HFA 68180-0963-01 Lupin Pharm. A209954 Generic
Ventolin® HFA 00173-0682-20 GSK 18 gm N020983 Brand BX
Albuterol sulfate HFA 66993-0019-68 Prasco Labs N020983 NDA Authorized Generic
ProAir RespiClick® 59310-0580-20 Teva Resp. 1 EA N205636 Single Source Brand
ProAir® Digihaler® 59310-0117-20 Teva Resp. N205636 Single Source Brand

Meredith Thiede, PharmD