Prescription drug · ANDA
Ranitidine NDC 64980-637
Ranitidine hydrochloride 300 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-637-03 | 6498006370364980063703 | 30 TABLET in 1 BOTTLE (64980-637-03)Marketed from Dec 6, 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)
- Ranitidine
- Generic name (nonproprietary)
- ranitidine
- Active ingredients
- Ranitidine hydrochloride — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 64980
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211289
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 64980-637_b4d3aa30-82b1-45e5-89bb-829c5ccf7ffeSPL ID b4d3aa30-82b1-45e5-89bb-829c5ccf7ffeSPL set ID 0fba6615-37c2-4ba6-b6e5-09599369a5bcRxCUI 198191, 198193UNII BK76465IHMUPC 0364980637039
- 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
N464980063703followed by a unit qualifier and the quantityPackage 64980-0637-03. 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)
INDICATIONS AND USAGE Ranitidine Tablets are indicated in: Short- term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of Ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo- controlled comparative studies have been carried out for periods of longer than 1 year. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). Short-term treatment of active, benign gastric ulcers. Most patients heal within 6 weeks and the usefulness …
Excerpt only. Read the full label for complete information.
About NDC 64980-637
- What is NDC 64980-637?
- 64980-637 is the product NDC for Ranitidine, Ranitidine hydrochloride 300 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ranitidine.
- What is the active ingredient?
- Ranitidine hydrochloride.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 64980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ranitidine?
- 12 other product NDCs are listed under this name. See all Ranitidine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ranitidine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ranitidine | Ranitidine hydrochloride 150 mg/1 | TabletOral | Atland Pharmaceuticals, LLC | 71993-314 | 71993-0314-30 |
| Ranitidine | Ranitidine hydrochloride 300 mg/1 | TabletOral | Atland Pharmaceuticals, LLC | 71993-315 | 71993-0315-30 |
| Ranitidine | Ranitidine hydrochloride 150 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-636 | 64980-0636-03 |
| Ranitidine | Ranitidine hydrochloride 150 mg/1 | TabletOral | Granules India Ltd | 62207-773 | 62207-0773-3662207-0773-4162207-0773-47+1 more |
| Ranitidine | Ranitidine hydrochloride 150 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-109 | 27241-0109-0627241-0109-50 |
| Ranitidine | Ranitidine hydrochloride 300 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-110 | 27241-0110-0327241-0110-10 |
| Ranitidine | Ranitidine 15 mg/mL | SyrupOral | Pharmaceutical Associates, Inc. | 0121-0727 | 00121-0727-16 |
| Ranitidine | Ranitidine 15 mg/mL | SyrupOral | Pharmaceutical Associates, Inc. | 0121-4727 | 00121-4727-10 |
| Ranitidine | Ranitidine hydrochloride 150 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-253 | 53746-0253-0153746-0253-0553746-0253-10+2 more |
| Ranitidine | Ranitidine hydrochloride 300 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-254 | 53746-0254-0153746-0254-0253746-0254-30 |
Other NDCs under ANDA 211289
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 |
|---|---|---|---|---|
| Ranitidine | Ranitidine hydrochloride 150 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-636 |
| Ranitidine | Ranitidine hydrochloride 150 mg/1 | TabletOral | Atland Pharmaceuticals, LLC | 71993-314 |
| Ranitidine | Ranitidine hydrochloride 300 mg/1 | TabletOral | Atland Pharmaceuticals, LLC | 71993-315 |