Prescription drug · ANDA
Dicyclomine Hydrochloride NDC 68788-8751
Dicyclomine hydrochloride 20 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8751-2 | 6878887510268788875102 | 20 TABLET in 1 BOTTLE, PLASTIC (68788-8751-2)Marketed from Sep 13, 2023 | |
| 68788-8751-3 | 6878887510368788875103 | 30 TABLET in 1 BOTTLE, PLASTIC (68788-8751-3)Marketed from Oct 11, 2024 | |
| 68788-8751-6 | 6878887510668788875106 | 60 TABLET in 1 BOTTLE, PLASTIC (68788-8751-6)Marketed from Oct 11, 2024 | |
| 68788-8751-9 | 6878887510968788875109 | 90 TABLET in 1 BOTTLE, PLASTIC (68788-8751-9)Marketed from Oct 11, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217916
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 68788-8751_00f785fd-3c18-4e62-a0c2-18ce7ae30f25SPL ID 00f785fd-3c18-4e62-a0c2-18ce7ae30f25SPL set ID 3ee013cc-ab23-40a1-a44d-1d027c63b132RxCUI 991086UNII CQ903KQA31
- 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
N468788875102followed by a unit qualifier and the quantityPackage 68788-8751-02. 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)
Dicyclomine hydrochloride tablets are indicated for the treatment of patients with functional bowel/irritable bowel syndrome. Dicyclomine hydrochloride is an antispasmodic and anticholinergic (antimuscarinic) agent indicated for the treatment of functional bowel/irritable bowel syndrome ( ).
Excerpt only. Read the full label for complete information.
About NDC 68788-8751
- What is NDC 68788-8751?
- 68788-8751 is the product NDC for Dicyclomine Hydrochloride, Dicyclomine hydrochloride 20 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 4 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 217916
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 | A-S Medication Solutions | 50090-7882 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Bionpharma Inc. | 69452-311 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2506 |
| Dicyclomine Hydrochloride | Dicyclomine hydrochloride 20 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-103 |