NDC codes

FDA NDC Directory
Product NDC (as listed)50090-4347Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-4347Add 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
50090-4347-0500904347001 TUBE in 1 CARTON (50090-4347-0) / 45 g in 1 TUBEMarketed from Jun 11, 2019

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)
Tretinoin
Generic name (nonproprietary)
tretinoin
Active ingredients
Tretinoin1 mg/g
Dosage form
Cream
Route
Topical
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211645
Marketing start
Listing expires
Other FDA classes
Retinoids (Chemical structure)
Identifiers
Product ID 50090-4347_30e66646-8fed-4a3b-acc9-2028c00d5da8SPL ID 30e66646-8fed-4a3b-acc9-2028c00d5da8SPL set ID da206984-4ded-4d5c-8a23-323920466a5fRxCUI 198300UNII 5688UTC01R
Pharmacologic class
Retinoid

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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450090434700 followed by a unit qualifier and the quantity

Package 50090-4347-00. 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 Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 211645

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211645
ProductStrengthForm · routeLabelerProduct NDC
TretinoinTretinoin 1 mg/gCreamTopicalNORTHSTAR RX LLC16714-250
TretinoinTretinoin 1 mg/gCreamTopicalNuCare Pharmaceuticals,Inc.68071-3889
TretinoinTretinoin 1 mg/gCreamTopicalSun Pharmaceutical Industries, Inc.51672-1395
TretinoinTretinoin 1 mg/gCreamTopicalNuCare Pharmaceuticals, Inc.68071-3826

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