Prescription drug · ANDA
Famotidine NDC 72865-215
Famotidine 40 mg/1 · Tablet, Film coated · Oral · XLCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72865-215-01 | 72865021501 | 100 TABLET, FILM COATED in 1 BOTTLE (72865-215-01)Marketed from Oct 15, 2021 | |
| 72865-215-05 | 72865021505 | 500 TABLET, FILM COATED in 1 BOTTLE (72865-215-05)Marketed from Oct 15, 2021 | |
| 72865-215-18 | 72865021518 | 180 TABLET, FILM COATED in 1 BOTTLE (72865-215-18)Marketed from Oct 15, 2021 | |
| 72865-215-30 | 72865021530 | 30 TABLET, FILM COATED in 1 BOTTLE (72865-215-30)Marketed from Oct 15, 2021 |
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)
- Famotidine
- Generic name (nonproprietary)
- famotidine
- Active ingredients
- Famotidine — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- XLCare Pharmaceuticals, Inc.NDC labeler code 72865
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215689
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 72865-215_b37fe9a5-6465-4518-823d-5d369a4c7793SPL ID b37fe9a5-6465-4518-823d-5d369a4c7793SPL set ID 7b550cf9-221f-4f28-ba99-414ad7d5612fRxCUI 284245, 310273UNII 5QZO15J2Z8UPC 0372865214015, 0372865214053, 0372865215180, 0372865215302, 0372865214305, 0372865215012, 0372865215050, 0372865214183
- 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
N472865021501followed by a unit qualifier and the quantityPackage 72865-0215-01. 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)
Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence. Famotidine is a histamine-2 (H 2 ) receptor antagonist indicated (1): In adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (DU). active gastric ulcer. symptoma…
Excerpt only. Read the full label for complete information.
About NDC 72865-215
- What is NDC 72865-215?
- 72865-215 is the product NDC for Famotidine, Famotidine 40 mg/1 tablet, film coated, listed with the FDA by XLCare Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Famotidine.
- What is the active ingredient?
- Famotidine.
- Who is the labeler?
- XLCare Pharmaceuticals, Inc., NDC labeler code 72865. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Famotidine?
- 254 other product NDCs are listed under this name. See all Famotidine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Famotidine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Famotidine | Famotidine 40 mg/5mL | Powder, For suspensionOral | NorthStar Rx LLC | 72603-564 | 72603-0564-01 |
| Famotidine | Famotidine 40 mg/5mL | Powder, For suspensionOral | RISING PHARMA HOLDINGS, INC. | 64980-737 | 64980-0737-50 |
| Famotidine | Famotidine 40 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4144 | 68788-4144-0368788-4144-0468788-4144-06+1 more |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0589 | 80425-0589-0180425-0589-0280425-0589-03 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Family Dollar Stores, LLC | 55319-057 | 55319-0057-1055319-0057-2555319-0057-50 |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-030 | 87441-0030-01 |
| Famotidine | Famotidine 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4119 | 68788-4119-0168788-4119-0368788-4119-04+3 more |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-150 | 48433-0150-20 |
| Famotidine | Famotidine 20 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals Inc. | 68788-4088 | 68788-4088-0368788-4088-0468788-4088-06+1 more |
| Famotidine | Famotidine 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4574 | 70518-4574-0070518-4574-0170518-4574-02+1 more |
Other NDCs under ANDA 215689
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 | Famotidine 20 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals, Inc. | 72865-214 |