What is NDC 21130-482?

21130-482 is the product NDC for signature care allergy and congestion relief, Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 tablet, film coated, extended release, listed with the FDA by Safeway. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

signature care allergy and congestion relief (Loratadine, Pseudoephedrine sulfate).

What is the active ingredient?

Loratadine, Pseudoephedrine sulfate.

Safeway, NDC labeler code 21130. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for signature care allergy and congestion relief?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 21130-482

NDC codes

FDA NDC Directory

Product NDC (as listed)21130-482Labeler and product segments. Claims need a package NDC.

Product NDC at billing width21130-0482Add 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 NDC	11-digit (billing)	Package	Copy
21130-482-60	2113004826021130048260	20 BLISTER PACK in 1 CARTON (21130-482-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 2, 2018

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): signature care allergy and congestion relief
Generic name (nonproprietary): loratadine, pseudoephedrine sulfate
Active ingredients: Loratadine — 5 mg/1Pseudoephedrine sulfate — 120 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: SafewayNDC labeler code 21130
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076050
Marketing start: Apr 2, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)
Identifiers: Product ID 21130-482_35ee6029-73f0-4239-9983-a1af2565c005SPL ID 35ee6029-73f0-4239-9983-a1af2565c005SPL set ID e1993d05-248e-48da-838c-068f8263c2ebRxCUI 1242399UNII 7AJO3BO7QN, Y9DL7QPE6B
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

N421130048260 followed by a unit qualifier and the quantity

Package 21130-0482-60. 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 Mar 8, 2021.

Indications (excerpt from the label)

Uses • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • sneezing • itchy, watery eyes • runny nose • itching of the nose or throat • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 21130-482

What is NDC 21130-482?: 21130-482 is the product NDC for signature care allergy and congestion relief, Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1 tablet, film coated, extended release, listed with the FDA by Safeway. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: signature care allergy and congestion relief (Loratadine, Pseudoephedrine sulfate).
What is the active ingredient?: Loratadine, Pseudoephedrine sulfate.
Who is the labeler?: Safeway, NDC labeler code 21130. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for signature care allergy and congestion relief?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 076050

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

FDA NDC Directory listings under ANDA 076050
Product	Strength	Form · route	Labeler	Product NDC
Alavert Allergy and Congestion D-12 hourloratadine and pseudoephedrine sulfate	Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1	Tablet, Film coated, Extended releaseOral	Foundation Consumer Brands	80070-100
Allergy and Congestion Reliefloratadine, pseudoephedrine sulfate	Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1	Tablet, Film coated, Extended releaseOral	L. Perrigo Company	0113-2007
allergy and nasal congestionloratadine, pseudoephedrine sulfate	Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1	Tablet, Film coated, Extended releaseOral	Kroger Company	30142-850
allergy relief dloratadine, pseudoephedrine sulfate	Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1	Tablet, Film coated, Extended releaseOral	Meijer Distribution Inc	41250-954
allergy relief dloratadine, pseudoephedrine sulfate	Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1	Tablet, Film coated, Extended releaseOral	Publix Super Markets Inc	56062-555
allergy relief d 12loratadine, pseudoephedrine sulfate	Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1	Tablet, Film coated, Extended releaseOral	Walgreen Company	0363-7023
allergy relief d 12loratadine, pseudoephedrine sulfate	Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1	Tablet, Film coated, Extended releaseOral	CVS Pharmacy	69842-641
equate allergy and congestion reliefloratadine, pseudoephedrine sulfate	Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1	Tablet, Film coated, Extended releaseOral	Wal-Mart Stores Inc	49035-643
foster and thrive allergy D 12 hourloratadine, pseudoephedrine sulfate	Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1	Tablet, Film coated, Extended releaseOral	Strategic Sourcing Services LLC	70677-1024
good neighbor pharmacy loratadine dloratadine, pseudoephedrine sulfate	Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1	Tablet, Film coated, Extended releaseOral	Amerisource Bergen	46122-455
kirkland signature allerclear d 12 hrloratadine, pseudoephedrine sulfate	Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1	Tablet, Film coated, Extended releaseOral	Costco Wholesale Company	63981-723
Leader Allergy Relief D12loratadine, pseudoephedrine sulfate	Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1	Tablet, Film coated, Extended releaseOral	Cardinal Health 110, LLC. dba Leader	70000-0504
loratadine Dloratadine, pseudoephedrine sulfate	Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1	Tablet, Film coated, Extended releaseOral	Padagis Israel Pharmaceuticals Ltd	45802-122
loratadine Dloratadine, pseudoephedrine sulfate	Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1	Tablet, Film coated, Extended releaseOral	Sportpharm LLC	85766-047
perrigo allergy dloratadine, pseudoephedrine sulfate	Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1	Tablet, Film coated, Extended releaseOral	L. Perrigo Company	0113-7777
topcare allergy and congestion reliefloratadine, pseudoephedrine sulfate	Loratadine 5 mg/1; Pseudoephedrine sulfate 120 mg/1	Tablet, Film coated, Extended releaseOral	Topco Associates LLC	36800-611

signature care allergy and congestion relief (Loratadine, pseudoephedrine sulfate) NDC 21130-482