NDC codes

FDA NDC Directory
Product NDC (as listed)42847-106Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42847-0106Add 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
42847-106-034284701060330 TABLET in 1 BLISTER PACK (42847-106-03)Marketed from Aug 1, 2010
42847-106-1042847010610100 TABLET in 1 BOTTLE (42847-106-10)Marketed from Aug 1, 2010
42847-106-304284701063030 TABLET in 1 BOTTLE (42847-106-30)Marketed from Aug 1, 2010
42847-106-5042847010650500 TABLET in 1 BOTTLE (42847-106-50)Marketed from Aug 1, 2010

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)
Silenor
Generic name (nonproprietary)
doxepin hydrochloride
Active ingredients
Doxepin hydrochloride — 6 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022036
Marketing start
Listing expires
Identifiers
Product ID 42847-106_cd7bcf13-11a5-4866-9fd0-da073bb3a9a1SPL ID cd7bcf13-11a5-4866-9fd0-da073bb3a9a1SPL set ID 1bec1223-5239-4eb6-a9e8-62444106d2c0RxCUI 966787, 966791, 966793, 966795UNII 3U9A0FE9N5UPC 0342847103309, 0342847106300
Pharmacologic class
Tricyclic Antidepressant

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

N442847010603 followed by a unit qualifier and the quantity

Package 42847-0106-03. 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)

1. INDICATIONS AND USAGE SILENOR is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration . SILENOR (doxepin) tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. ( 1 , 14 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022036

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

FDA NDC Directory listings under NDA 022036
ProductStrengthForm · routeLabelerProduct NDC
doxepin hydrochlorideDoxepin hydrochloride 6 mg/1TabletOralCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven44183-106
doxepin hydrochlorideDoxepin hydrochloride 3 mg/1TabletOralCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven44183-103
Silenordoxepin hydrochlorideDoxepin hydrochloride 3 mg/1TabletOralCurrax Pharmaceuticals LLC42847-103

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