grisofulvin

Generic: grisofulvin

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name grisofulvin
Generic Name grisofulvin
Labeler cipla usa inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

griseofulvin 125 mg/5mL

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-361
Product ID 69097-361_6cf78fd3-5be6-412c-acdf-f599efaf0654
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065354
Listing Expiration 2026-12-31
Marketing Start 2017-03-06

Pharmacologic Class

Established (EPC)
tubulin inhibiting agent [epc]
Physiologic Effect
decreased mitosis [pe] microtubule inhibition [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097361
Hyphenated Format 69097-361

Supplemental Identifiers

RxCUI
239238
UPC
0369097361082
UNII
32HRV3E3D5
NUI
N0000008732 N0000175085 N0000175848

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name grisofulvin (source: ndc)
Generic Name grisofulvin (source: ndc)
Application Number ANDA065354 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/5mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE (69097-361-08)
source: ndc

Packages (1)

69097-361-08 120 mL in 1 BOTTLE (69097-361-08)

Ingredients (1)

griseofulvin (125 mg/5mL)

Linked Drug Pages (1)

grisofulvin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6cf78fd3-5be6-412c-acdf-f599efaf0654", "openfda": {"nui": ["N0000008732", "N0000175085", "N0000175848"], "upc": ["0369097361082"], "unii": ["32HRV3E3D5"], "rxcui": ["239238"], "spl_set_id": ["d5c737e5-51b8-4322-a2a5-4d4a392c1f56"], "pharm_class_pe": ["Decreased Mitosis [PE]", "Microtubule Inhibition [PE]"], "pharm_class_epc": ["Tubulin Inhibiting Agent [EPC]"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (69097-361-08)", "package_ndc": "69097-361-08", "marketing_start_date": "20170306"}], "brand_name": "grisofulvin", "product_id": "69097-361_6cf78fd3-5be6-412c-acdf-f599efaf0654", "dosage_form": "SUSPENSION", "pharm_class": ["Decreased Mitosis [PE]", "Microtubule Inhibition [PE]", "Tubulin Inhibiting Agent [EPC]"], "product_ndc": "69097-361", "generic_name": "grisofulvin", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "grisofulvin", "active_ingredients": [{"name": "GRISEOFULVIN", "strength": "125 mg/5mL"}], "application_number": "ANDA065354", "marketing_category": "ANDA", "marketing_start_date": "20170306", "listing_expiration_date": "20261231"}