Prescription drug · ANDA
Dicyclomine hydrochloride NDC 72789-466
Dicyclomine hydrochloride 20 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72789-466-01 | 7278904660172789046601 | 100 TABLET in 1 BOTTLE, PLASTIC (72789-466-01)Marketed from Dec 27, 2024 | |
| 72789-466-30 | 7278904663072789046630 | 30 TABLET in 1 BOTTLE, PLASTIC (72789-466-30)Marketed from Jul 28, 2025 | |
| 72789-466-82 | 7278904668272789046682 | 500 TABLET in 1 BOTTLE, PLASTIC (72789-466-82)Marketed from Dec 27, 2024 | |
| 72789-466-90 | 7278904669072789046690 | 90 TABLET in 1 BOTTLE, PLASTIC (72789-466-90)Marketed from Sep 3, 2025 | |
| 72789-466-95 | 7278904669572789046695 | 1000 TABLET in 1 BOTTLE, PLASTIC (72789-466-95)Marketed from Dec 27, 2024 |
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)
- Dicyclomine hydrochloride
- Generic name (nonproprietary)
- dicyclomine hydrochloride
- Active ingredients
- Dicyclomine hydrochloride — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 72789
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216736
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 72789-466_5b89a57c-2651-a68b-e063-6294a90a9eb6SPL ID 5b89a57c-2651-a68b-e063-6294a90a9eb6
- Pharmacologic class
- Anticholinergic
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
N472789046601followed by a unit qualifier and the quantityPackage 72789-0466-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 72789-466
- What is NDC 72789-466?
- 72789-466 is the product NDC for Dicyclomine hydrochloride, Dicyclomine hydrochloride 20 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dicyclomine hydrochloride.
- What is the active ingredient?
- Dicyclomine hydrochloride.
- Who is the labeler?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 72789. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dicyclomine hydrochloride?
- 126 other product NDCs are listed under this name. See all Dicyclomine hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dicyclomine 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) |
|---|---|---|---|---|---|
| dicyclomine hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc. | 0054-0883 | 00054-0883-2500054-0883-31 |
| dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0885 | 00054-0885-2500054-0885-31 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4146 | 68788-4146-03 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Advagen Pharma Ltd., | 72888-105 | 72888-0105-0072888-0105-0172888-0105-05+1 more |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-007 | 87441-0007-01 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | Coupler LLC | 67046-1258 | 67046-1258-03 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Coupler LLC | 67046-1164 | 67046-1164-03 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-103 | 82868-0103-30 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4555 | 70518-4555-00 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 10 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-522 | 72789-0522-0172789-0522-2072789-0522-28+5 more |
Other NDCs under ANDA 216736
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 |
|---|---|---|---|---|
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8622 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-7732 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-548 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-802 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Redpharm Drug | 67296-2142 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Redpharm Drug | 67296-2175 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2226 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Advagen Pharma Ltd., | 72888-119 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 40 mg/1 | TabletOral | Advagen Pharma Ltd., | 72888-198 |
| Dicyclomine hydrochloride | Dicyclomine hydrochloride 40 mg/1 | TabletOral | Trifluent Pharma, LLC | 73352-119 |