Over-the-counter drug · ANDA

nasal decongestant (Pseudoephedrine hydrochloride) NDC 70677-0001

Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Extended release · Oral · Strategic Sourcing Services

NDC codes

FDA NDC Directory
Product NDC (as listed)70677-0001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70677-0001Add 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
70677-0001-170677000101706770001011 BLISTER PACK in 1 CARTON (70677-0001-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 5, 2018

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)
nasal decongestant
Generic name (nonproprietary)
pseudoephedrine hydrochloride
Active ingredients
Pseudoephedrine hydrochloride — 120 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Strategic Sourcing ServicesNDC labeler code 70677
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 70677-0001_a6862b77-0e04-41d5-927f-6b521df4b34cSPL ID a6862b77-0e04-41d5-927f-6b521df4b34cSPL set ID 53acd8d9-b9d8-4a38-8597-32043548d832RxCUI 1049154UNII 6V9V2RYJ8N
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

N470677000101 followed by a unit qualifier and the quantity

Package 70677-0001-01. 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)

Uses • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily relieves sinus congestion and pressure

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70677-0001

What is NDC 70677-0001?
70677-0001 is the product NDC for nasal decongestant (pseudoephedrine hydrochloride), Pseudoephedrine hydrochloride 120 mg/1 tablet, extended release, listed with the FDA by Strategic Sourcing Services. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
nasal decongestant (Pseudoephedrine Hydrochloride).
What is the active ingredient?
Pseudoephedrine hydrochloride.
Who is the labeler?
Strategic Sourcing Services, NDC labeler code 70677. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for nasal decongestant?
14 other product NDCs are listed under this name. See all 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 nasal decongestant NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
nasal decongestantoxymetazoline hydrochlorideOxymetazoline hydrochloride .05 g/100mLSprayNasalSafeway21130-83721130-0837-10
nasal decongestantoxymetazoline hydrochlorideOxymetazoline hydrochloride .05 g/100mLSprayNasalSafeway21130-80721130-0807-10
nasal decongestantoxymetazoline hydrochlorideOxymetazoline hydrochloride .05 g/100mLSprayNasalSafeway21130-42021130-0420-10
nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralMeijer Distribution Inc41250-80941250-0809-5241250-0809-60
nasal decongestantoxymetazoline hclOxymetazoline hydrochloride .05 g/100mLSprayNasalA-S Medication Solutions50090-528150090-5281-00
Nasal Decongestantcamellia sinensis, ephedra vulgaris, belladonna, arsenicum album, cinnabaris, kali bichromicum, pulsatilla, sepia, calcarea carbonica, mercurius solubilis, sulphurCamellia sinensis whole 4 [hp_X]/mL + 10 more ingredientsLiquidOralNatural Creations, Inc43406-069343406-0693-01
Nasal Decongestantpseudoephedrine hclPseudoephedrine hydrochloride 30 mg/1TabletOralRugby Laboratories0536-360700536-3607-35
Nasal Decongestantpseudoephedrine hclPseudoephedrine hydrochloride 30 mg/1TabletOralProficient Rx LP63187-34463187-0344-24
nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralHyVee Inc42507-05442507-0054-5242507-0054-60
nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralPublix Super Markets Inc56062-05456062-0054-60

All 15 nasal decongestant NDCs

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
12 Hour Nasal Decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coatedOralCARDINAL HEALTH70000-0656
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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