NDC codes

FDA NDC Directory
Product NDC (as listed)68682-513Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68682-0513Add 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
68682-513-8268682051382686820513821 TUBE in 1 CARTON (68682-513-82) / 20 g in 1 TUBEMarketed from Mar 14, 2013
68682-513-8468682051384686820513841 TUBE in 1 CARTON (68682-513-84) / 45 g in 1 TUBEMarketed from Mar 14, 2013
68682-513-8568682051385686820513851 BOTTLE, PUMP in 1 CARTON (68682-513-85) / 50 g in 1 BOTTLE, PUMPMarketed from Mar 14, 2013

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 — 1 mg/g
Dosage form
Gel
Route
Topical
Labeler
Oceanside PharmaceuticalsNDC labeler code 68682
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 020475
Marketing start
Listing expires
Other FDA classes
Retinoids (Chemical structure)
Identifiers
Product ID 68682-513_c4ef7e4d-9c2e-4022-b7ab-b55962c1a58aSPL ID c4ef7e4d-9c2e-4022-b7ab-b55962c1a58aSPL set ID d3c528d2-429d-4f37-9ebf-eee8b9fd3050RxCUI 313453, 359050, 1488045UNII 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

N468682051382 followed by a unit qualifier and the quantity

Package 68682-0513-82. 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)

Tretinoin Gel Microsphere is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. Tretinoin Gel Microsphere is a retinoid indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68682-513

What is NDC 68682-513?
68682-513 is the product NDC for Tretinoin, Tretinoin 1 mg/g gel, listed with the FDA by Oceanside Pharmaceuticals. It has 3 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?
Oceanside Pharmaceuticals, NDC labeler code 68682. 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 NDA 020475

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

FDA NDC Directory listings under NDA 020475
ProductStrengthForm · routeLabelerProduct NDC
Retin-A MICROtretinoinTretinoin 1 mg/gGelTopicalBausch Health US LLC0187-5140
Retin-A MICROtretinoinTretinoin .4 mg/gGelTopicalBausch Health US LLC0187-5144
Retin-A MICROtretinoinTretinoin .6 mg/gGelTopicalBausch Health US LLC0187-5146
Retin-A MICROtretinoinTretinoin .8 mg/gGelTopicalBausch Health US LLC0187-5148
TretinoinTretinoin .4 mg/gGelTopicalOceanside Pharmaceuticals68682-514
TretinoinTretinoin .8 mg/gGelTopicalOceanside Pharmaceuticals68682-515

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