Over-the-counter drug · ANDA

sinus and nasal decongestant (Pseudoephedrine hydrochloride) NDC 51316-616

Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Film coated, Extended release · Oral · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

NDC codes

FDA NDC Directory
Product NDC (as listed)51316-616Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51316-0616Add 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
51316-616-52513160616525131606165210 BLISTER PACK in 1 CARTON (51316-616-52) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jan 20, 2026
51316-616-60513160616605131606166020 BLISTER PACK in 1 CARTON (51316-616-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jan 28, 2026

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)
sinus and nasal decongestant
Generic name (nonproprietary)
pseudoephedrine hydrochloride
Active ingredients
Pseudoephedrine hydrochloride — 120 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075153
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)
Identifiers
Product ID 51316-616_00329fc8-144a-4254-8482-87adab8d9685SPL ID 00329fc8-144a-4254-8482-87adab8d9685SPL set ID e39daa3c-1901-4966-b85e-ab76d7bd1216RxCUI 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

N451316061652 followed by a unit qualifier and the quantity

Package 51316-0616-52. 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 51316-616

What is NDC 51316-616?
51316-616 is the product NDC for sinus and nasal decongestant (pseudoephedrine hydrochloride), Pseudoephedrine hydrochloride 120 mg/1 tablet, film coated, extended release, listed with the FDA by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
sinus and nasal decongestant (Pseudoephedrine Hydrochloride).
What is the active ingredient?
Pseudoephedrine hydrochloride.
Who is the labeler?
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, NDC labeler code 51316. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for sinus and nasal decongestant?
2 other product NDCs are listed under this name. See all sinus and 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 sinus and nasal decongestant NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Sinus And Nasal Decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 30 mg/1Tablet, Film coatedOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-31751316-0317-6251316-0317-80
Sinus and Nasal Decongestantpseudoephedrine hclPseudoephedrine hydrochloride 30 mg/1Tablet, Film coatedOralCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED51316-12151316-0121-22

Other NDCs under ANDA 075153

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

FDA NDC Directory listings under ANDA 075153
ProductStrengthForm · routeLabelerProduct NDC
12 Hour Nasal Decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCVS Pharmacy59779-703
CareOne Nasal and Sinus Decongestantpseudoephedrine hclPseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralAmerican Sales Company41520-429
Equaline 12 Hour Decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralUnited Natural Foods, Inc. dba UNFI41163-054
equate sinus 12 hourpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralWal-Mart Stores Inc49035-508
good neighbor pharmacy nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralAmerisource Bergen24385-054
Good Sense Suphedrine 12 Hourpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-0054
leader 12 hour nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0475
Leader 12 Hour Sinus Nasal Decongestantpseudoephedrine hclPseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralCardinal Health 110, LLC. dba Leader70000-0735
nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralMeijer Distribution Inc41250-809
nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralHyVee Inc42507-054
nasal decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralPublix Super Markets Inc56062-054
Nasal Decongestant Dpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralWalgreen Company0363-3301
pseudoephedrine hydrochloridepseudoephedrine hclPseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralPadagis Israel Pharmaceuticals Ltd45802-107
sinus 12 hourpseudoephedrine hclPseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralL. Perrigo Company0113-2017
sinus pressure and congestion relief maximum strengthpseudoephedrine hclPseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralRite Aid Corporation11822-0650
Sudafed Sinus Congestion 12 Hourpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralA-S Medication Solutions50090-4629
Sudafed Sinus Congestion 12 Hourpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralKenvue Brands LLC50580-242
SudoGest 12 Hourpseudoephedrine hclPseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralMajor Pharmaceuticals0904-6754
topcare 12 hour decongestantpseudoephedrine hydrochloridePseudoephedrine hydrochloride 120 mg/1Tablet, Film coated, Extended releaseOralTopco Associates LLC36800-054

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