FDA Orange Book
Generic for Zemplar
Zemplar contains paricalcitol. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Zemplar is paricalcitol. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Zemplar products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 1MCG | Discontinued | None | 7 | AB |
| capsule, oral | 2MCG | Discontinued | None | 7 | AB |
| capsule, oral | 4MCG | Discontinued | None | 7 | AB |
| solution, intravenous | 0.002MG/ML (0.002MG/ML) | Marketed (Rx) | AP | 2 | AP |
| solution, intravenous | 0.005MG/ML (0.005MG/ML) | Marketed (Rx) | AP | 3 | AP |
| solution, intravenous | 0.01MG/2ML (0.005MG/ML) | Marketed (Rx) | AP | 3 | AP |
NDA 021606, 020819, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic paricalcitol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 091108 | AP (A-rated, therapeutically equivalent) | July 27, 2011 | 0.002MG/ML (0.002MG/ML), 0.005MG/ML (0.005MG/ML), 0.01MG/2ML (0.005MG/ML) |
| TEVA PHARMACEUTICALS USA | 090829 | AB (A-rated, therapeutically equivalent) | September 27, 2013 | 1MCG, 2MCG, 4MCG |
| BIONPHARMA INC | 202539 | AB (A-rated, therapeutically equivalent) | March 27, 2014 | 1MCG, 2MCG, 4MCG |
| CHARTWELL RX SCIENCES LLC | 091412 | AB (A-rated, therapeutically equivalent) | June 24, 2014 | 1MCG, 2MCG, 4MCG |
| RISING PHARMA HOLDINGS INC | 202124 | AB (A-rated, therapeutically equivalent) | June 24, 2014 | 1MCG, 2MCG, 4MCG |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 204327 | AB (A-rated, therapeutically equivalent) | January 13, 2016 | 1MCG, 2MCG, 4MCG |
| AUROBINDO PHARMA LTD | 207672 | AB (A-rated, therapeutically equivalent) | January 14, 2016 | 1MCG, 2MCG, 4MCG |
| PHARMAZONE | 204948 | AB (A-rated, therapeutically equivalent) | October 7, 2016 | 1MCG, 2MCG, 4MCG |
| AMNEAL PHARMACEUTICALS CO GMBH | 206699 | AP (A-rated, therapeutically equivalent) | March 9, 2017 | 0.002MG/ML (0.002MG/ML), 0.005MG/ML (0.005MG/ML), 0.01MG/2ML (0.005MG/ML) |
| RISING PHARMA HOLDINGS INC | 203897 | AP (A-rated, therapeutically equivalent) | November 2, 2017 | 0.005MG/ML (0.005MG/ML), 0.01MG/2ML (0.005MG/ML) |
Zemplar NDC codes
Questions
Is there a generic for Zemplar?
Yes. The generic name for Zemplar is paricalcitol. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Zemplar?
The active ingredient in Zemplar is paricalcitol, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.