Prescription drug · ANDA
Glycopyrrolate NDC 70069-012
Glycopyrrolate .2 mg/mL · Injection · Intramuscular, Intravenous · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-012-25 | 7006900122570069001225 | 25 VIAL in 1 CARTON (70069-012-25) / 2 mL in 1 VIAL (70069-012-01)Marketed from Jan 29, 2022 |
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)
- Glycopyrrolate
- Generic name (nonproprietary)
- glycopyrrolate
- Active ingredients
- Glycopyrrolate — .2 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Somerset Therapeutics, LLCNDC labeler code 70069
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211705
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Antagonists (Mechanism)
- Identifiers
- Product ID 70069-012_1cf06d0b-356a-4f2a-af3c-bbcd7e24aae9SPL ID 1cf06d0b-356a-4f2a-af3c-bbcd7e24aae9SPL set ID a46c5ec1-a1b4-46fc-9b37-8da7f0c983d6RxCUI 238212, 1731582, 1731590UNII V92SO9WP2IUPC 0370069011010, 0370069012017, 0370069013014, 0370069014011
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N470069001225followed by a unit qualifier and the quantityPackage 70069-0012-25. 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 & USAGE In Anesthesia: Glycopyrrolate Injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug‑induced or vagal reflexes associated arrhythmias. Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blocka…
Excerpt only. Read the full label for complete information.
About NDC 70069-012
- What is NDC 70069-012?
- 70069-012 is the product NDC for Glycopyrrolate, Glycopyrrolate .2 mg/mL injection, listed with the FDA by Somerset Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Glycopyrrolate.
- What is the active ingredient?
- Glycopyrrolate.
- Who is the labeler?
- Somerset Therapeutics, LLC, NDC labeler code 70069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Glycopyrrolate?
- 179 other product NDCs are listed under this name. See all Glycopyrrolate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Glycopyrrolate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Glycopyrrolate | Glycopyrrolate 1 mg/5mL | SolutionOral | QUAGEN PHARMACEUTICALS LLC | 70752-175 | 70752-0175-12 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4671 | 70518-4671-00 |
| glycopyrrolate | Glycopyrrolate 1 mg/5mL | SolutionOral | Bionpharma Inc. | 69452-406 | 69452-0406-88 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4597 | 70518-4597-00 |
| Glycopyrrolate | Glycopyrrolate 1 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-110 | 71921-0110-01 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | Florida Pharmaceutical Products, LLC | 71921-111 | 71921-0111-01 |
| Glycopyrrolate | Glycopyrrolate .2 mg/mL | InjectionIntramuscular, Intravenous | Jvet Pharmaceuticals LLC | 86211-113 | 86211-0113-10 |
| Glycopyrrolate | Glycopyrrolate 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4537 | 70518-4537-00 |
| Glycopyrrolate | Glycopyrrolate .2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9776 | 00404-9776-05 |
| Glycopyrrolate | Glycopyrrolate .2 mg/mL | Injection, SolutionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9777 | 00404-9777-20 |
Other NDCs under ANDA 211705
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 |
|---|---|---|---|---|
| Glycopyrrolate | Glycopyrrolate 4 mg/20mL | InjectionIntramuscular, Intravenous | Caplin Steriles Limited | 65145-105 |
| Glycopyrrolate | Glycopyrrolate 1 mg/5mL | InjectionIntramuscular, Intravenous | Caplin Steriles Limited | 65145-104 |
| Glycopyrrolate | Glycopyrrolate .2 mg/mL | InjectionIntramuscular, Intravenous | Caplin Steriles Limited | 65145-102 |
| Glycopyrrolate | Glycopyrrolate .4 mg/2mL | InjectionIntramuscular, Intravenous | Caplin Steriles Limited | 65145-103 |
| Glycopyrrolate | Glycopyrrolate .2 mg/mL | InjectionIntramuscular, Intravenous | Somerset Therapeutics, LLC | 70069-011 |
| Glycopyrrolate | Glycopyrrolate .2 mg/mL | InjectionIntramuscular, Intravenous | Somerset Therapeutics, LLC | 70069-013 |
| Glycopyrrolate | Glycopyrrolate .2 mg/mL | InjectionIntramuscular, Intravenous | Somerset Therapeutics, LLC | 70069-014 |
| glycopyrrolate | Glycopyrrolate .2 mg/mL | InjectionIntramuscular, Intravenous | BE Pharmaceuticals Inc. | 71839-123 |
| glycopyrrolate | Glycopyrrolate .4 mg/2mL | InjectionIntramuscular, Intravenous | BE Pharmaceuticals Inc. | 71839-124 |
| glycopyrrolate | Glycopyrrolate 1 mg/5mL | InjectionIntramuscular, Intravenous | BE Pharmaceuticals Inc. | 71839-125 |
| glycopyrrolate | Glycopyrrolate 4 mg/20mL | InjectionIntramuscular, Intravenous | BE Pharmaceuticals Inc. | 71839-126 |