Over-the-counter drug · ANDA
Anti-Diarrheal/Anti-Gas (Loperamide hydrochloride, simethicone) NDC 53943-263
Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 · Tablet · Oral · Discount Drug Mart, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53943-263-33 | 5394302633353943026333 | 4 BLISTER PACK in 1 CARTON (53943-263-33) / 6 TABLET in 1 BLISTER PACKMarketed from Feb 26, 2025 |
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)
- Anti-Diarrheal/Anti-Gas
- Generic name (nonproprietary)
- loperamide hydrochloride, simethicone
- Active ingredients
- Loperamide hydrochloride — 2 mg/1Dimethicone — 125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Discount Drug Mart, IncNDC labeler code 53943
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214541
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)Skin Barrier Activity (Physiologic effect)
- Identifiers
- Product ID 53943-263_e44c3937-4a74-46c4-a467-398229e5aeceSPL ID e44c3937-4a74-46c4-a467-398229e5aeceSPL set ID 2e0b3aec-f436-c0fb-e063-6394a90abb51RxCUI 978001UNII 77TI35393C, 92RU3N3Y1OUPC 0093351033209
- 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
N453943026333followed by a unit qualifier and the quantityPackage 53943-0263-33. 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)
USE(S) 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 53943-263
- What is NDC 53943-263?
- 53943-263 is the product NDC for Anti-Diarrheal/Anti-Gas, Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 tablet, listed with the FDA by Discount Drug Mart, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Anti-Diarrheal/Anti-Gas (Loperamide Hydrochloride, Simethicone).
- What is the active ingredient?
- Loperamide hydrochloride, Dimethicone.
- Who is the labeler?
- Discount Drug Mart, Inc, NDC labeler code 53943. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Anti-Diarrheal/Anti-Gas?
- 5 other product NDCs are listed under this name. See all Anti-Diarrheal/Anti-Gas NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Anti-Diarrheal/Anti-Gas products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| anti diarrheal anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | HyVee Inc | 42507-699 | 42507-0699-5342507-0699-62 |
| Anti-Diarrheal/Anti-Gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Harris Teeter, LLC | 69256-265 | 69256-0265-3169256-0265-3369256-0265-73 |
| Anti Diarrheal Anti Gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Kroger Company | 30142-581 | 30142-0581-5330142-0581-62 |
| anti diarrheal anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Rite Aid Corporation | 11822-1003 | 11822-1003-0211822-1003-03 |
| anti diarrheal anti gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | H E B | 37808-714 | 37808-0714-5337808-0714-62 |
Other NDCs under ANDA 214541
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 |
|---|---|---|---|---|
| Anti-Diarrheal/Anti-Gasloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Harris Teeter, LLC | 69256-265 |
| Anti-Diarrheal/Anti-Gas Multi-Symptom Reliefloperamide hydrochloride 2mg, simethicone 125mg | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Wal-Mart Stores, Inc. | 79903-116 |
| Equate Anti Diarrheal Anti Gas Multi-Symptom Reliefloperamide hydrochloride, simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | WALMART INC. | 79903-302 |
| Loperamide Hydrochloride, Simethicone | Loperamide hydrochloride 2 mg/1; Dimethicone 125 mg/1 | TabletOral | Guardian Drug Company | 53041-263 |