NCPDP Package Size Updates: Gonal-f® RFF Redi-ject® and Teriparatide (Alvogen)
Similar to the recent package size changes for Forteo®, NCPDP reports that the FDA has requested product labeling changes on four additional products which will be revised in compendia this summer. The FDA is not requiring manufacturers to obtain new NDCs and there are no clinical changes to the products.
Products with coming package size changes include:
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| Product | NDC | Old Package Size | New Package Size | Compendia Date |
| Teriparatide (Alvogen) | 47781-0652-89 | 2.48 mL | 2.24 mL | July 1, 2025 |
| Gonal-f® RFF Redi-ject® | 44087-1117-01 | 1.5 mL | 1.44 mL | July 1, 2025 |
| 44087-1115-01 | 0.5 mL | 0.48 mL | August 1, 2025 | |
| 44087-1116-01 | 0.75 mL | 0.72 mL | August 1, 2025 |
Alvogen’s teriparatide will have the strength corrected from 620 mg/2.48 mL to 560 mcg/2.24 mL to accurately reflect the intended delivery of 28 daily doses of 20 mcg. Products with revised labeling should be in the marketplace by mid-June 2025.
EMD Serono, Inc’s Gonal-f® RFF Redi-ject® (follitropoin alfa injection) will correct the currently rounded number volumes to more accurately reflect the volume delivered in a single patient use prefilled pen. Products with revised labeling should enter the marketplace in mid-June and mid-July 2025.
PAAS Tips:
- Be careful when adjudicating claims and ensure that you bill for the quantity of the product in-hand
- Pharmacies may need to contact PBM helpdesks if claims are paid incorrectly (overpay or underpay) or reject altogether
I obtained my PharmD from the University of Wisconsin-Madison School of Pharmacy and worked for a major chain as well as various LTC and independent pharmacies, before coming to PAAS.
I am passionate about learning and teaching. I strive to learn something new about PBM audits every day, so that PAAS can be more knowledgeable to better serve our members! In 2018, I started traveling to state pharmacy conferences to present audit seminars and meet our wonderful members in person.
- NCPDP Package Size Updates: Gonal-f® RFF Redi-ject® and Teriparatide (Alvogen) - July 29, 2025
- Medicare Prescription Drug Coverage and Your Rights (CMS-10147) - June 28, 2025
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