NDC codes

FDA NDC Directory
Product NDC (as listed)51672-3007Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51672-3007Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
51672-3007-151672300701516723007011 BOTTLE in 1 CARTON (51672-3007-1) / 10 mL in 1 BOTTLEMarketed from Apr 28, 2005

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Hydrocortisone and Acetic Acid
Generic name (nonproprietary)
hydrocortisone and acetic acid
Active ingredients
Hydrocortisone — 10.4 mg/mLAcetic acid — 20.8 mg/mL
Dosage form
Solution
Route
Auricular (Otic)
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 088759
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 51672-3007_395a20ab-856b-3f08-e063-6294a90aa48eSPL ID 395a20ab-856b-3f08-e063-6294a90aa48eSPL set ID 6383c722-84e2-4719-a13d-19c54e3eefffUNII WI4X0X7BPJ, Q40Q9N063P
Pharmacologic class
Corticosteroid

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N451672300701 followed by a unit qualifier and the quantity

Package 51672-3007-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51672-3007

What is NDC 51672-3007?
51672-3007 is the product NDC for Hydrocortisone and Acetic Acid, Hydrocortisone 10.4 mg/mL; Acetic acid 20.8 mg/mL solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Hydrocortisone and Acetic Acid.
What is the active ingredient?
Hydrocortisone, Acetic acid.
Who is the labeler?
Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Hydrocortisone and Acetic Acid?
2 other product NDCs are listed under this name. See all Hydrocortisone and Acetic Acid NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Hydrocortisone and Acetic Acid NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
hydrocortisone and acetic acidhydrocortisone and acetic acid oticAcetic acid 20.75 mg/mL; Hydrocortisone 10.375 mg/mLSolutionAuricular (Otic)Saptalis Pharmaceuticals, LLC71656-06471656-0064-10
hydrocortisone and acetic acidAcetic acid 20 mg/mL; Hydrocortisone 10 mg/mLSolutionAuricular (Otic)Cosette Pharmaceuticals, Inc.0713-084900713-0849-09

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