NDC codes

FDA NDC Directory
Product NDC (as listed)68462-792Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0792Add 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
68462-792-016846207920168462079201100 CAPSULE in 1 BOTTLE (68462-792-01)Marketed from Dec 23, 2016

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 — 10 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208279
Marketing start
Listing expires
Other FDA classes
Retinoids (Chemical structure)
Identifiers
Product ID 68462-792_5761f729-3e1f-4fe7-9d5f-cfb652bf1625SPL ID 5761f729-3e1f-4fe7-9d5f-cfb652bf1625SPL set ID 264138c1-9e5f-45ef-be87-79ca97c989d9RxCUI 199159UNII 5688UTC01RUPC 0368462792018
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468462079201 followed by a unit qualifier and the quantity

Package 68462-0792-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated. Tretinoin capsules are a retinoid indicated for induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL), characterized by presence of t(15;17) translocation or presence of PML/RARα gene expression, and who are refractory to or who have relaps…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68462-792

What is NDC 68462-792?
68462-792 is the product NDC for Tretinoin, Tretinoin 10 mg/1 capsule, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 1 package NDC, 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?
Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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

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