Over-the-counter drug · ANDA
Maximum Strength Acid Reducer (Famotidine) NDC 49483-720
Famotidine 20 mg/1 · Tablet · Oral · TIME CAP LABORATORIES,INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-720-01 | 4948307200149483072001 | 100 TABLET in 1 BOTTLE (49483-720-01)Marketed from Mar 11, 2024 | |
| 49483-720-20 | 4948307202049483072020 | 200 TABLET in 1 BOTTLE (49483-720-20)Marketed from Jun 15, 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)
- Maximum Strength Acid Reducer
- Generic name (nonproprietary)
- famotidine
- Active ingredients
- Famotidine — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES,INCNDC labeler code 49483
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217543
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 49483-720_12f9b308-9375-2df3-e063-6394a90a8d22SPL ID 12f9b308-9375-2df3-e063-6394a90a8d22SPL set ID fe25e1e2-7158-6fe0-e053-6394a90a3bb1RxCUI 310273UNII 5QZO15J2Z8UPC 0349483720013
- Pharmacologic class
- Histamine-2 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
N449483072001followed by a unit qualifier and the quantityPackage 49483-0720-01. 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 relieves heartburn associated with acid indigestion and sour stomach prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
Excerpt only. Read the full label for complete information.
About NDC 49483-720
- What is NDC 49483-720?
- 49483-720 is the product NDC for Maximum Strength Acid Reducer (famotidine), Famotidine 20 mg/1 tablet, listed with the FDA by TIME CAP LABORATORIES,INC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Maximum Strength Acid Reducer (Famotidine).
- What is the active ingredient?
- Famotidine.
- Who is the labeler?
- TIME CAP LABORATORIES,INC, NDC labeler code 49483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Maximum Strength Acid Reducer?
- 1 other product NDC are listed under this name. See all Maximum Strength Acid Reducer NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Maximum Strength Acid Reducer products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Maximum Strength Acid Reducerfamotidine | Famotidine 20 mg/1 | TabletOral | TARGET CORPORATION | 11673-697 | 11673-0697-0111673-0697-0511673-0697-20+1 more |
Other NDCs under ANDA 217543
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 |
|---|---|---|---|---|
| Famotidine 10 mg | Famotidine 10 mg/1 | Tablet, CoatedOral | MARKSANS PHARMA LIMITED | 25000-086 |
| Famotidine 20 mg | Famotidine 20 mg/1 | Tablet, CoatedOral | MARKSANS PHARMA LIMITED | 25000-087 |
| Famotidine 20 mg | Famotidine 20 mg/1 | Tablet, CoatedOral | MARKSANS PHARMA LIMITED | 25000-124 |
| Maximum Strength Acid Controllerfamotidine | Famotidine 20 mg/1 | TabletOral | BETTER LIVING BRANDS LLC. | 21130-027 |
| Maximum Strength Acid Reducerfamotidine | Famotidine 20 mg/1 | TabletOral | TARGET CORPORATION | 11673-697 |
| Original strength heartburn preventionfamotidine | Famotidine 10 mg/1 | TabletOral | KROGER COMPANY | 41226-719 |