Acetic Acid

Product NDC
68071-2984
11-digit product format
680712984
Labeler code
68071
Product ID
68071-2984_2dcdd631-b9c5-e301-e063-6294a90a038f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetic Acid
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA040607
Marketing category
ANDA
Marketing start
2020-06-05
Substance
ACETIC ACID
Active strength
20.65 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetic Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETIC ACID20.65 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ40Q9N063P
Rxcui197305

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2984-52025-02-10C16284748780-12cef2736-97da-d83d-e063-dadaa90ab31fAcetic Acid Otic Solution, USP
68071-2984-52025-01-30C16284748780-12cef2736-97da-d83d-e063-dadaa90ab31fAcetic Acid Otic Solution, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2984-5Acetic Acid15 mL in 1 BOTTLESOLUTION152
68071-2984-5Acetic Acid1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2984ACETIC ACID SOLUTION [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 2 package rows20250212_f9b4d18b-25f3-604f-e053-6394a90a5531.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197305acetic acid 2 % Otic SolutionPSNf9b4d18b-25f3-604f-e053-6394a90a55312
197305acetic acid 20 MG/ML Otic SolutionSCDf9b4d18b-25f3-604f-e053-6394a90a55312
197305acetic acid 2 % Otic SolutionSYf9b4d18b-25f3-604f-e053-6394a90a55312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-2984-5680712984051 BOTTLE in 1 CARTON (68071-2984-5) / 15 mL in 1 BOTTLE1 bottle2023-04-19NoNoHistorical