Over-the-counter drug · ANDA
12HR Allergy Relief (Fexofenadine hydrochloride) NDC 70000-0586
Fexofenadine hydrochloride 60 mg/1 · Tablet · Oral · CARDINAL HEALTH
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70000-0586-1 | 70000058601 | 1 BLISTER PACK in 1 CARTON (70000-0586-1) / 12 TABLET in 1 BLISTER PACKMarketed from Sep 24, 2021 |
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)
- 12HR Allergy Relief
- Generic name (nonproprietary)
- fexofenadine hydrochloride
- Active ingredients
- Fexofenadine hydrochloride — 60 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- CARDINAL HEALTHNDC labeler code 70000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211075
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70000-0586_ccc271cc-6aa2-f753-e053-2995a90a1161SPL ID ccc271cc-6aa2-f753-e053-2995a90a1161SPL set ID ea5d0e55-2191-4094-b082-24b317f95752RxCUI 997501UNII 2S068B75ZUUPC 0096295141474
- Pharmacologic class
- Histamine-1 Receptor Antagonist
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
N470000058601followed by a unit qualifier and the quantityPackage 70000-0586-01. 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 these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 70000-0586
- What is NDC 70000-0586?
- 70000-0586 is the product NDC for 12HR Allergy Relief (fexofenadine hydrochloride), Fexofenadine hydrochloride 60 mg/1 tablet, 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?
- 12HR Allergy Relief (Fexofenadine Hydrochloride).
- What is the active ingredient?
- Fexofenadine 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 12HR Allergy 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 211075
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 |
|---|---|---|---|---|
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | HEB | 37808-391 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | CVS PHARMACY | 69842-492 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | HEB | 37808-392 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Family Dollar (FAMILY WELLNESS) | 55319-965 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Capsule, CoatedOral | Allegiant Health | 69168-413 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | TARGET CORPORATION | 11673-767 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | TabletOral | WALMART INC. (see also Equate) | 79903-090 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Safrel Pharmaceuticals, LLC. | 71309-091 |
| Fexofenadine Hydrochloride | Fexofenadine hydrochloride 180 mg/1 | Tablet, Film coatedOral | AMZ789 LLC | 73629-008 |
| Allergy Relieffexofenadine hcl | Fexofenadine hydrochloride 180 mg/1 | Tablet, CoatedOral | FSA Store Inc. (Caring Mills) | 81522-613 |
| Allergy Relief Non Drowsyfexofenadine hcl | Fexofenadine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Allegiant Health | 69168-437 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 60 mg/1 | TabletOral | HARRIS TEETER | 72036-191 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Meijer, Inc. | 79481-6230 |
| allergy relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | United Natural Foods, Inc. dba UNFI | 41163-292 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Meijer | 79481-7660 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | TOPCO ASSOCIATES LLC | 36800-653 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Bi-Mart | 37835-602 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | CHAIN DRUG MARKETING ASSOCIATION INC | 63868-334 |
| Allergy Relieffexofenadine hydrochloride | Fexofenadine hydrochloride 180 mg/1 | TabletOral | AMERIFOODS TRADING COMPANY | 61504-192 |
| Fexofenadine HCL | Fexofenadine hydrochloride 180 mg/1 | TabletOral | Walgreens | 0363-9760 |
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