Prescription drug · ANDA
Ranitidine Hydrochloride NDC 55111-129
Ranitidine hydrochloride 150 mg/1 · Capsule · Oral · Dr. Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-129-05 | 5511101290555111012905 | 500 CAPSULE in 1 BOTTLE (55111-129-05)Marketed from Jan 12, 2001 | |
| 55111-129-60 | 5511101296055111012960 | 60 CAPSULE in 1 BOTTLE (55111-129-60)Marketed from Jan 12, 2001 |
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 Hydrochloride
- Generic name (nonproprietary)
- ranitidine hydrochloride
- Active ingredients
- Ranitidine hydrochloride — 150 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Dr. Reddy's Laboratories LimitedNDC labeler code 55111
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075742
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 55111-129_9741e6f4-a2dc-7543-1138-da97eafe11bdSPL ID 9741e6f4-a2dc-7543-1138-da97eafe11bdSPL set ID 7bf94bf7-fa11-70be-9f65-fe26a3db5a63RxCUI 198190, 198192UNII BK76465IHM
- 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
N455111012905followed by a unit qualifier and the quantityPackage 55111-0129-05. 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 is indicated in: 1. 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. 2. 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. 3.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). 4. Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness o…
Excerpt only. Read the full label for complete information.
About NDC 55111-129
- What is NDC 55111-129?
- 55111-129 is the product NDC for Ranitidine Hydrochloride, Ranitidine hydrochloride 150 mg/1 capsule, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ranitidine Hydrochloride.
- What is the active ingredient?
- Ranitidine hydrochloride.
- Who is the labeler?
- Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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 Hydrochloride?
- 1 other product NDC are listed under this name. See all Ranitidine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ranitidine Hydrochloride 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 Hydrochloride | Ranitidine hydrochloride 300 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Limited | 55111-130 | 55111-0130-0155111-0130-30 |
Other NDCs under ANDA 075742
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 Hydrochloride | Ranitidine hydrochloride 300 mg/1 | CapsuleOral | Dr. Reddy's Laboratories Limited | 55111-130 |