hydrocortisone and acetic acid

Generic: hydrocortisone and acetic acid otic

Labeler: saptalis pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone and acetic acid
Generic Name hydrocortisone and acetic acid otic
Labeler saptalis pharmaceuticals, llc
Dosage Form SOLUTION
Routes
AURICULAR (OTIC)
Active Ingredients

acetic acid 20.75 mg/mL, hydrocortisone 10.375 mg/mL

Manufacturer
Saptalis Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 71656-064
Product ID 71656-064_339e0417-4d1a-e168-e063-6294a90a50bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA012770
Listing Expiration 2026-12-31
Marketing Start 2024-02-23

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71656064
Hyphenated Format 71656-064

Supplemental Identifiers

RxCUI
313786
UNII
Q40Q9N063P WI4X0X7BPJ
NUI
N0000175576 N0000175450

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 hydrocortisone and acetic acid (source: ndc)
Generic Name hydrocortisone and acetic acid otic (source: ndc)
Application Number NDA012770 (source: ndc)
Routes
AURICULAR (OTIC)
source: ndc

Resolved Composition

Strengths
  • 20.75 mg/mL
  • 10.375 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (71656-064-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

71656-064-10 1 BOTTLE, DROPPER in 1 CARTON (71656-064-10) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (2)

acetic acid (20.75 mg/mL) hydrocortisone (10.375 mg/mL)

Linked Drug Pages (1)

hydrocortisone and acetic acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["AURICULAR (OTIC)"], "spl_id": "339e0417-4d1a-e168-e063-6294a90a50bb", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["Q40Q9N063P", "WI4X0X7BPJ"], "rxcui": ["313786"], "spl_set_id": ["d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Saptalis Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (71656-064-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "71656-064-10", "marketing_start_date": "20240223"}], "brand_name": "hydrocortisone and acetic acid", "product_id": "71656-064_339e0417-4d1a-e168-e063-6294a90a50bb", "dosage_form": "SOLUTION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "71656-064", "generic_name": "hydrocortisone and acetic acid otic", "labeler_name": "Saptalis Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "hydrocortisone and acetic acid", "active_ingredients": [{"name": "ACETIC ACID", "strength": "20.75 mg/mL"}, {"name": "HYDROCORTISONE", "strength": "10.375 mg/mL"}], "application_number": "NDA012770", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20240223", "listing_expiration_date": "20261231"}