Prescription drug · NDA AUTHORIZED GENERIC
Pilocarpine hydrochloride NDC 68084-928
Pilocarpine hydrochloride 5 mg/1 · Tablet, Film coated · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-928-25 | 6808409282568084092825 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-928-25) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-928-95)Marketed from Sep 25, 2015 |
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)
- Pilocarpine hydrochloride
- Generic name (nonproprietary)
- pilocarpine hydrochloride
- Active ingredients
- Pilocarpine hydrochloride — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- American Health PackagingNDC labeler code 68084
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020237
- Marketing start
- Marketing end
- Other FDA classes
- Cholinergic Agonists (Mechanism)Cholinergic Muscarinic Agonists (Mechanism)
- Identifiers
- Product ID 68084-928_4911bf7f-0c0c-fde7-e063-6394a90ac636SPL ID 4911bf7f-0c0c-fde7-e063-6394a90ac636SPL set ID 6f950741-fd3f-4bf7-83b0-f5aa9dbceb76RxCUI 1000913UNII 0WW6D218XJ
- Pharmacologic class
- Cholinergic Receptor Agonist
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
N468084092825followed by a unit qualifier and the quantityPackage 68084-0928-25. 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 Pilocarpine Hydrochloride Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.
Excerpt only. Read the full label for complete information.
About NDC 68084-928
- What is NDC 68084-928?
- 68084-928 is the product NDC for Pilocarpine hydrochloride, Pilocarpine hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by American Health Packaging. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pilocarpine hydrochloride.
- What is the active ingredient?
- Pilocarpine hydrochloride.
- Who is the labeler?
- American Health Packaging, NDC labeler code 68084. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pilocarpine hydrochloride?
- 21 other product NDCs are listed under this name. See all Pilocarpine hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pilocarpine 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) |
|---|---|---|---|---|---|
| Pilocarpine Hydrochloride | Pilocarpine hydrochloride 5 mg/1 | Tablet, Film coatedOral | AMICI PHARMACEUTICALS LLC | 69292-265 | 69292-0265-01 |
| Pilocarpine Hydrochloride | Pilocarpine hydrochloride 5 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-652 | 50268-0652-12 |
| Pilocarpine Hydrochloride | Pilocarpine hydrochloride 10 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 69238-1745 | 69238-1745-08 |
| Pilocarpine Hydrochloride | Pilocarpine hydrochloride 20 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 69238-1746 | 69238-1746-08 |
| Pilocarpine Hydrochloride | Pilocarpine hydrochloride 40 mg/mL | Solution/ dropsOphthalmic | Amneal Pharmaceuticals NY LLC | 69238-1747 | 69238-1747-08 |
| Pilocarpine Hydrochloridepilocarpine hydrochloride ophthalmic solution | Pilocarpine hydrochloride 10 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-181 | 70069-0181-01 |
| Pilocarpine Hydrochloridepilocarpine hydrochloride ophthalmic solution | Pilocarpine hydrochloride 20 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-191 | 70069-0191-01 |
| Pilocarpine Hydrochloridepilocarpine hydrochloride ophthalmic solution | Pilocarpine hydrochloride 40 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-201 | 70069-0201-01 |
| Pilocarpine Hydrochloride | Pilocarpine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-224 | 59651-0224-01 |
| Pilocarpine Hydrochloride | Pilocarpine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-225 | 59651-0225-01 |
Other NDCs under NDA 020237
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 |
|---|---|---|---|---|
| Pilocarpine hydrochloride | Pilocarpine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Actavis Pharma, Inc. | 0228-2801 |
| Pilocarpine hydrochloride | Pilocarpine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Actavis Pharma, Inc. | 0228-2837 |
| Salagenpilocarpine hydrochloride | Pilocarpine hydrochloride 5 mg/1 | Tablet, Film coatedOral | Advanz Pharma (US) Corp. | 59212-705 |
| Salagenpilocarpine hydrochloride | Pilocarpine hydrochloride 7.5 mg/1 | Tablet, Film coatedOral | Advanz Pharma (US) Corp. | 59212-775 |