NDC codes

FDA NDC Directory
Product NDC (as listed)0187-5164Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00187-5164Add 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
0187-5164-20001875164201 TUBE in 1 CARTON (0187-5164-20) / 20 g in 1 TUBEMarketed from Apr 30, 1973
0187-5164-45001875164451 TUBE in 1 CARTON (0187-5164-45) / 45 g in 1 TUBEMarketed from Apr 30, 1973

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Retin-A
Generic name (nonproprietary)
tretinoin
Active ingredients
Tretinoin — 1 mg/g
Dosage form
Cream
Route
Topical
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 017340
Marketing start
Listing expires
Other FDA classes
Retinoids (Chemical structure)
Identifiers
Product ID 0187-5164_18a7b6d8-e3c4-676f-e063-6294a90a0498SPL ID 18a7b6d8-e3c4-676f-e063-6294a90a0498SPL set ID 9556d73d-c573-4e0a-9feb-764ce2d1107bRxCUI 106302, 106303, 198300, 208328, 208330, 208331, 208334, 313450, 313451, 701305UNII 5688UTC01RUPC 0301875170455, 0301875172459
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

N400187516420 followed by a unit qualifier and the quantity

Package 00187-5164-20. 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 RETIN-A 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 NDA 017340

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

FDA NDC Directory listings under NDA 017340
ProductStrengthForm · routeLabelerProduct NDC
Tretinoin CreamtretinoinTretinoin 1 mg/gCreamTopicalObagi Cosmeceuticals LLC62032-417
TretinoinTretinoin 1 mg/gCreamTopicalMylan Pharmaceuticals Inc.0378-8084

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