Prescription drug · NDA
Rectiv (Nitroglycerin) NDC 58914-301
Nitroglycerin 4 mg/g · Ointment · Rectal · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58914-301-80 | 5891403018058914030180 | 1 TUBE in 1 CARTON (58914-301-80) / 30 g in 1 TUBEMarketed from Jun 21, 2011 |
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)
- Rectiv
- Generic name (nonproprietary)
- nitroglycerin
- Active ingredients
- Nitroglycerin — 4 mg/g
- Dosage form
- Ointment
- Route
- Rectal
- Labeler
- Allergan, Inc.NDC labeler code 58914
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021359
- Marketing start
- Marketing end
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 58914-301_5af7594b-3ed9-ce68-e063-6394a90a006eSPL ID 5af7594b-3ed9-ce68-e063-6394a90a006eSPL set ID 603aa9ed-54c4-4a35-ade4-690fa44850e4RxCUI 1114466, 1114470UNII G59M7S0WS3
- Pharmacologic class
- Nitrate Vasodilator
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.
- NDC on a medical claim
N458914030180followed by a unit qualifier and the quantityPackage 58914-0301-80. 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)
RECTIV ® (nitroglycerin) Ointment 0.4% is indicated for the treatment of moderate to severe pain associated with chronic anal fissure. RECTIV is a nitrate vasodilator indicated for the treatment of moderate to severe pain associated with chronic anal fissure ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 58914-301
- What is NDC 58914-301?
- 58914-301 is the product NDC for Rectiv (nitroglycerin), Nitroglycerin 4 mg/g ointment, listed with the FDA by Allergan, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rectiv (Nitroglycerin).
- What is the active ingredient?
- Nitroglycerin.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 58914. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rectiv?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.