Over-the-counter drug · ANDA
Loperamide Hydrochloride and Simethicone NDC 21130-222
Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 · Tablet · Oral · Better Living Brands, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21130-222-24 | 21130022224 | 4 BLISTER PACK in 1 CARTON (21130-222-24) / 6 TABLET in 1 BLISTER PACKMarketed from Jul 21, 2023 | |
| 21130-222-76 | 21130022276 | 3 BLISTER PACK in 1 CARTON (21130-222-76) / 6 TABLET in 1 BLISTER PACKMarketed from Jul 21, 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)
- Loperamide Hydrochloride and Simethicone
- Generic name (nonproprietary)
- loperamide hydrochloride and simethicone
- Active ingredients
- Loperamide hydrochloride — 2 mg/1Dimethicone — 125 mg/1
- Dosage form
- Tablet
- 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 211059
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)Skin Barrier Activity (Physiologic effect)
- Identifiers
- Product ID 21130-222_d9e5ddb4-1b09-440f-82af-b3dd59ef3ec0SPL ID d9e5ddb4-1b09-440f-82af-b3dd59ef3ec0SPL set ID fad9a144-6d1e-be06-e053-6394a90a870cRxCUI 978001UNII 77TI35393C, 92RU3N3Y1O
- Pharmacologic class
- Opioid 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
N421130022224followed by a unit qualifier and the quantityPackage 21130-0222-24. 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 relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Excerpt only. Read the full label for complete information.
About NDC 21130-222
- What is NDC 21130-222?
- 21130-222 is the product NDC for Loperamide Hydrochloride and Simethicone, Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 tablet, listed with the FDA by Better Living Brands, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loperamide Hydrochloride and Simethicone.
- What is the active ingredient?
- Loperamide hydrochloride, Dimethicone.
- 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 Loperamide Hydrochloride and Simethicone?
- 13 other product NDCs are listed under this name. See all Loperamide Hydrochloride and Simethicone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Loperamide Hydrochloride and Simethicone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Loperamide hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Bionpharma Inc. | 69452-531 | 69452-0531-12 |
| Loperamide Hydrochloride and Simethicone | Dimethicone 125 mg/1; Loperamide hydrochloride 2 mg/1 | TabletOral | IMO-GEN LABS LLC | 84441-713 | 84441-0713-10 |
| Loperamide Hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | FSA store INC | 81522-325 | 81522-0325-24 |
| Loperamide Hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | WALMART INC. | 79903-223 | 79903-0223-1279903-0223-24 |
| Loperamide Hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Family Dollar Stores, LLC | 55319-052 | 55319-0052-75 |
| Loperamide Hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Granules India Ltd | 62207-739 | 62207-0739-69 |
| Loperamide Hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | WALGREEN CO. | 0363-9606 | 00363-9606-7500363-9606-76 |
| Loperamide hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Bionpharma Inc. | 69452-210 | 69452-0210-0469452-0210-12 |
| Loperamide Hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | NORTHEAST PHARMA | 80136-384 | 80136-0384-24 |
| Loperamide Hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Camber Consumer Care Inc | 69230-325 | 69230-0325-0469230-0325-0669230-0325-08+3 more |
Other NDCs under ANDA 211059
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 |
|---|---|---|---|---|
| Loperamide Hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | WALGREEN CO. | 0363-9606 |
| Loperamide Hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Family Dollar Stores, LLC | 55319-052 |
| Loperamide Hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Aurohealth LLC | 58602-815 |
| Loperamide Hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Aurohealth LLC | 58602-868 |
| Loperamide Hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Aurohealth LLC | 58602-869 |
| Loperamide Hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | WALMART INC. | 79903-223 |
| Loperamide Hydrochloride and Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | NORTHEAST PHARMA | 80136-384 |