Over-the-counter drug · ANDA
Pseudoephedrine HCl NDC 21130-158
Pseudoephedrine hydrochloride 120 mg/1 · Tablet, Extended release · Oral · Better Living Brands LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21130-158-67 | 21130015867 | 2 BLISTER PACK in 1 CARTON (21130-158-67) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Sep 1, 2023 |
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)
- Pseudoephedrine HCl
- Generic name (nonproprietary)
- pseudoephedrine hcl
- Active ingredients
- Pseudoephedrine hydrochloride — 120 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Better Living Brands LLCNDC labeler code 21130
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209008
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 21130-158_14aa89a7-5eb1-4037-a169-cbb527b46e95SPL ID 14aa89a7-5eb1-4037-a169-cbb527b46e95SPL set ID f9d5a22a-3964-08b8-e053-6294a90ab220RxCUI 1049154UNII 6V9V2RYJ8NUPC 0387730788560
- 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
N421130015867followed by a unit qualifier and the quantityPackage 21130-0158-67. 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.
About NDC 21130-158
- What is NDC 21130-158?
- 21130-158 is the product NDC for Pseudoephedrine HCl, Pseudoephedrine hydrochloride 120 mg/1 tablet, extended release, listed with the FDA by Better Living Brands LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pseudoephedrine HCl.
- What is the active ingredient?
- Pseudoephedrine hydrochloride.
- Who is the labeler?
- Better Living Brands LLC, 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 Pseudoephedrine HCl?
- 3 other product NDCs are listed under this name. See all Pseudoephedrine HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pseudoephedrine HCl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| pseudoephedrine HCl | Pseudoephedrine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7669 | 00904-7669-06 |
| Pseudoephedrine HCl | Pseudoephedrine hydrochloride 30 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6990 | 00904-6990-61 |
| Pseudoephedrine HCl | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-804 | 58602-0804-6758602-0804-83 |
Other NDCs under ANDA 209008
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Pseudoephedrine HCl | Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Extended releaseOral | Aurohealth LLC | 58602-804 |