Isotretinoin Capsule
FDA Label NDC 70771-1663

The following Structured Product Label (SPL) was submitted to the FDA by Zydus Lifesciences Limited for the product Isotretinoin (NDC 70771-1663). 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 package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Package Label.Principal Display Panel

NDC 70771-1662-8

Isotretinoin Capsules USP, 10 mg

30 Capsules

Rx only

10 mg (26618883 D91c 476e B22c 4d0e204b9dd3 01)

10 mg (26618883 D91c 476e B22c 4d0e204b9dd3 02)

NDC 70771-1663-8

Isotretinoin Capsules USP, 20 mg

30 Capsules

Rx only

20 mg (26618883 D91c 476e B22c 4d0e204b9dd3 03)

20 mg (26618883 D91c 476e B22c 4d0e204b9dd3 04)

NDC 70771-1664-8

Isotretinoin Capsules USP, 25 mg

30 Capsules

Rx only

25 mg (26618883 D91c 476e B22c 4d0e204b9dd3 05)

25 mg (26618883 D91c 476e B22c 4d0e204b9dd3 06)

NDC 70771-1665-8

Isotretinoin Capsules USP, 30 mg

30 Capsules

Rx only

30 mg (26618883 D91c 476e B22c 4d0e204b9dd3 07)

30 mg (26618883 D91c 476e B22c 4d0e204b9dd3 08)

NDC 70771-1666-8

Isotretinoin Capsules USP, 35 mg

30 Capsules

Rx only

35 mg (26618883 D91c 476e B22c 4d0e204b9dd3 09)

35 mg (26618883 D91c 476e B22c 4d0e204b9dd3 10)

NDC 70771-1667-8

Isotretinoin Capsules USP, 40 mg

30 Capsules

Rx only

40 mg (26618883 D91c 476e B22c 4d0e204b9dd3 11)

40 mg (26618883 D91c 476e B22c 4d0e204b9dd3 12)

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