NDC codes

FDA NDC Directory
Product NDC (as listed)16714-249Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0249Add 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
16714-249-0116714024901167140249011 TUBE in 1 CARTON (16714-249-01) / 20 g in 1 TUBEMarketed from Feb 25, 2022
16714-249-0216714024902167140249021 TUBE in 1 CARTON (16714-249-02) / 45 g in 1 TUBEMarketed from Feb 25, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Tretinoin
Generic name (nonproprietary)
tretinoin
Active ingredients
Tretinoin — .5 mg/g
Dosage form
Cream
Route
Topical
Labeler
NORTHSTAR RX LLCNDC labeler code 16714
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211644
Marketing start
Listing expires
Other FDA classes
Retinoids (Chemical structure)
Identifiers
Product ID 16714-249_39809045-c9fe-0fc5-e063-6394a90a60b0SPL ID 39809045-c9fe-0fc5-e063-6394a90a60b0SPL set ID 2e508351-eca3-427e-8d16-e840a84db0f5RxCUI 106303UNII 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

N416714024901 followed by a unit qualifier and the quantity

Package 16714-0249-01. 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 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)

About NDC 16714-249

What is NDC 16714-249?
16714-249 is the product NDC for Tretinoin, Tretinoin .5 mg/g cream, listed with the FDA by NORTHSTAR RX LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Tretinoin.
What is the active ingredient?
Tretinoin.
Who is the labeler?
NORTHSTAR RX LLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tretinoin?
68 other product NDCs are listed under this name. See all Tretinoin 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 Tretinoin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
TretinoinTretinoin .25 mg/gCreamTopicalZydus Lifesciences Limited70771-193370771-1933-0270771-1933-04
TretinoinTretinoin .25 mg/gCreamTopicalViona Pharmaceuticals Inc72578-15572578-0155-0872578-0155-09
TretinoinTretinoin .5 mg/gCreamTopicalAlembic Pharmaceuticals Limited46708-80846708-0808-0046708-0808-20
TretinoinTretinoin .5 mg/gCreamTopicalAlembic Pharmaceuticals Inc.62332-80862332-0808-2062332-0808-45
TretinoinTretinoin .8 mg/gGelTopicalAmneal Pharmaceuticals NY LLC69238-232369238-2323-01
TretinoinTretinoin .6 mg/gGelTopicalEncube Ethicals, Inc.21922-04221922-0042-40
TretinoinTretinoin .5 mg/gCreamTopicalEncube Ethicals, Inc.21922-07821922-0078-0621922-0078-25
TretinoinTretinoin 1 mg/gCreamTopicalEncube Ethicals, Inc.21922-07721922-0077-0621922-0077-25
TretinoinTretinoin .25 mg/gCreamTopicalPreferred Pharmaceuticals Inc.68788-406968788-4069-02
TretinoinTretinoin .25 mg/gCreamTopicalAlembic Pharmaceuticals Limited46708-80946708-0809-2046708-0809-45

All 69 Tretinoin NDCs

Other NDCs under ANDA 211644

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

FDA NDC Directory listings under ANDA 211644
ProductStrengthForm · routeLabelerProduct NDC
TretinoinTretinoin .5 mg/gCreamTopicalA-S Medication Solutions50090-6819
TretinoinTretinoin .5 mg/gCreamTopicalSun Pharmaceutical Industries, Inc.51672-1394
TretinoinTretinoin .5 mg/gCreamTopicalNuCare Pharmaceuticals,Inc.68071-3865

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