NDC codes

FDA NDC Directory
Product NDC (as listed)42806-143Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42806-0143Add 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
42806-143-0142806014301100 TABLET, FILM COATED in 1 BOTTLE (42806-143-01)Marketed from Feb 2, 2015
42806-143-0542806014305500 TABLET, FILM COATED in 1 BOTTLE (42806-143-05)Marketed from Feb 2, 2015
42806-143-304280601433030 TABLET, FILM COATED in 1 BOTTLE (42806-143-30)Marketed from Feb 2, 2015

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)
Demeclocycline Hydrochloride
Generic name (nonproprietary)
demeclocycline hydrochloride
Active ingredients
Demeclocycline hydrochloride — 150 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Epic Pharma, LLCNDC labeler code 42806
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065447
Marketing start
Listing expires
Other FDA classes
Tetracyclines (Chemical structure)
Identifiers
Product ID 42806-143_b84008e7-52db-4b3e-a12e-cb939852ff0fSPL ID b84008e7-52db-4b3e-a12e-cb939852ff0fSPL set ID 645af8f4-0843-4afb-9ddc-f587f38adb68RxCUI 905341, 905347UNII 29O079NTYTUPC 0342806144480, 0342806143018
Pharmacologic class
Tetracycline-class Antimicrobial

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

N442806014301 followed by a unit qualifier and the quantity

Package 42806-0143-01. 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 Demeclocycline hydrochloride tablets USP is indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by rickettsiae; Respiratory tract infections caused by Mycoplasma pneumoniae ; Lymphogranuloma venereum due to Chlamydia trachomatis ; Psittacosis (Ornithosis) due to Chlamydia psittaci ; Trachoma due to Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence; Inclusion conjunctivitis caused by Chlamydia trachomatis ; Nongonococcal ur…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42806-143

What is NDC 42806-143?
42806-143 is the product NDC for Demeclocycline Hydrochloride, Demeclocycline hydrochloride 150 mg/1 tablet, film coated, listed with the FDA by Epic Pharma, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Demeclocycline Hydrochloride.
What is the active ingredient?
Demeclocycline hydrochloride.
Who is the labeler?
Epic Pharma, LLC, NDC labeler code 42806. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Demeclocycline Hydrochloride?
9 other product NDCs are listed under this name. See all Demeclocycline Hydrochloride 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 Demeclocycline Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Demeclocycline HydrochloridedemeclocyclineDemeclocycline hydrochloride 300 mg/1TabletOralAmerican Health Packaging60687-70560687-0705-65
Demeclocycline HydrochloridedemeclocyclineDemeclocycline hydrochloride 150 mg/1TabletOralAmerican Health Packaging60687-69160687-0691-01
Demeclocycline HydrochloridedemeclocyclineDemeclocycline hydrochloride 300 mg/1TabletOralAmneal Pharmaceuticals of New York LLC53746-55553746-0555-48
Demeclocycline HydrochloridedemeclocyclineDemeclocycline hydrochloride 150 mg/1TabletOralAmneal Pharmaceuticals of New York LLC53746-55453746-0554-01
Demeclocycline HydrochlorideDemeclocycline hydrochloride 300 mg/1Tablet, Film coatedOralPuraCap Laboratories LLC24658-71124658-0711-48
Demeclocycline HydrochlorideDemeclocycline hydrochloride 150 mg/1Tablet, Film coatedOralPuraCap Laboratories LLC24658-71024658-0710-01
Demeclocycline HydrochlorideDemeclocycline hydrochloride 300 mg/1Tablet, Film coatedOralEpic Pharma, LLC42806-14442806-0144-0142806-0144-3042806-0144-48
Demeclocycline HydrochloridedemeclocyclineDemeclocycline hydrochloride 300 mg/1TabletOralAmneal Pharmaceuticals LLC65162-55565162-0555-48
Demeclocycline HydrochloridedemeclocyclineDemeclocycline hydrochloride 150 mg/1TabletOralAmneal Pharmaceuticals LLC65162-55465162-0554-10

Other NDCs under ANDA 065447

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

FDA NDC Directory listings under ANDA 065447
ProductStrengthForm · routeLabelerProduct NDC
Demeclocycline HydrochlorideDemeclocycline hydrochloride 300 mg/1Tablet, Film coatedOralEpic Pharma, LLC42806-144
Demeclocycline HydrochlorideDemeclocycline hydrochloride 300 mg/1Tablet, Film coatedOralPuraCap Laboratories LLC24658-711
Demeclocycline HydrochlorideDemeclocycline hydrochloride 150 mg/1Tablet, Film coatedOralPuraCap Laboratories LLC24658-710

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