Other
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Isotretinoin Capsule
FDA Label NDC 70771-1560
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Isotretinoin (NDC 70771-1560). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Package Label.Principal Display Panel
NDC 70771-1557-8
Isotretinoin Capsules, USP 10 mg
30 Capsules
Rx only
10 mg Front Label (4d21b9d2 C843 4313 86db Bec7d4145863 01)
10 mg Back (4d21b9d2 C843 4313 86db Bec7d4145863 02)
NDC 70771-1558-8
Isotretinoin Capsules, USP 20 mg
30 Capsules
Rx only
20 mg Front (4d21b9d2 C843 4313 86db Bec7d4145863 03)
20 mg Back (4d21b9d2 C843 4313 86db Bec7d4145863 04)
NDC 70771-1559-8
Isotretinoin Capsules, USP 30 mg
30 Capsules
Rx only
30 mg Front (4d21b9d2 C843 4313 86db Bec7d4145863 05)
30 mg Back (4d21b9d2 C843 4313 86db Bec7d4145863 06)
NDC 70771-1560-8
Isotretinoin Capsules, USP 40 mg
30 Capsules
Rx only
40 mg Front (4d21b9d2 C843 4313 86db Bec7d4145863 07)
40 mg Back (4d21b9d2 C843 4313 86db Bec7d4145863 08)
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