Prescription drug · ANDA
Cimetidine Hydrochloride NDC 68999-809
Cimetidine hydrochloride 300 mg/5mL · Solution · Oral · Chartwell Governmental & Specialty RX, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68999-809-24 | 68999080924 | 2 TRAY in 1 BOX (68999-809-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-809-05)Marketed from Oct 23, 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)
- Cimetidine Hydrochloride
- Generic name (nonproprietary)
- cimetidine hydrochloride
- Active ingredients
- Cimetidine hydrochloride — 300 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074251
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H2 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68999-809_42c607ee-eb27-a72c-e063-6394a90a653cSPL ID 42c607ee-eb27-a72c-e063-6394a90a653cSPL set ID e40bb1f6-338a-42e7-9217-8c32d14ccfd3RxCUI 212787UNII WF10491673
- 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
N468999080924followed by a unit qualifier and the quantityPackage 68999-0809-24. 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 Cimetidine Hydrochloride Oral Solution is indicated in: (1) Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see Dosage and Administration-Duodenal Ulcer ). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine. (2) Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment wi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074251
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 |
|---|---|---|---|---|
| Cimetidine Hydrochloride | Cimetidine hydrochloride 300 mg/5mL | SolutionOral | Chartwell RX, LLC | 62135-809 |