Over-the-counter drug · ANDA

12 Hour Nasal Decongestant (Pseudoephedrine hydrochloride) NDC 70000-0656

Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated · Oral · CARDINAL HEALTH

NDC codes

FDA NDC Directory
Product NDC (as listed)70000-0656Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70000-0656Add 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
70000-0656-170000065601700000656011 BLISTER PACK in 1 CARTON (70000-0656-1) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 16, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
12 Hour Nasal Decongestant
Generic name (nonproprietary)
pseudoephedrine hydrochloride
Active ingredients
Pseudoephedrine hydrochloride — 120 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
CARDINAL HEALTHNDC labeler code 70000
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077442
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)
Identifiers
Product ID 70000-0656_5ca698b7-443f-0c7a-e063-6294a90a46feSPL ID 5ca698b7-443f-0c7a-e063-6294a90a46fe
Pharmacologic class
alpha-Adrenergic Agonist

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

N470000065601 followed by a unit qualifier and the quantity

Package 70000-0656-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 70000-0656

What is NDC 70000-0656?
70000-0656 is the product NDC for 12 Hour Nasal Decongestant (pseudoephedrine hydrochloride), Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, listed with the FDA by CARDINAL HEALTH. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
12 Hour Nasal Decongestant (Pseudoephedrine hydrochloride).
What is the active ingredient?
Pseudoephedrine hydrochloride.
Who is the labeler?
CARDINAL HEALTH, NDC labeler code 70000. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for 12 Hour Nasal Decongestant?
1 other product NDC are listed under this name. See all 12 Hour Nasal Decongestant 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 12 Hour Nasal Decongestant NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
12 Hour Nasal Decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCVS Pharmacy59779-70359779-0703-5259779-0703-60

Other NDCs under ANDA 077442

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

FDA NDC Directory listings under ANDA 077442
ProductStrengthForm · routeLabelerProduct NDC
nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralStrategic Sourcing Services70677-0001
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralWalgreen Company0363-0204
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-7409
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralSafeway Inc.21130-204
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1TabletOralThe Kroger Company30142-967
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralHEB37808-007
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5554
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralOhm Laboratories Inc.51660-204
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralOhm Laboratories Inc.51660-492
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralDISCOUNT DRUG MART53943-204
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralPublix Super Markets Inc56062-204
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCVS Pharmacy59779-204
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Extended releaseOralSTRATEGIC SOURCING SERVICES LLC62011-0306
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralChain Drug Marketing Association Inc.63868-143
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralChain Drug Consortium, LLC68016-204
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralSAM'S WEST INC68196-204
Pseudoephedrine HydrochloridePseudoephedrine hydrochloride 120 mg/1TabletOralCARDINAL HEALTH 110, LLC DBA LEADER70000-0601
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralSTRATEGIC SOURCING SERVICES LLC70677-1019
Pseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralSportpharm LLC85766-050

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