Prescription drug · UNAPPROVED DRUG OTHER
Belladonna and Opium NDC 63629-8436
atropa belladonna and opium · Atropa belladonna 16.2 mg/1; Opium 30 mg/1 · Suppository · Rectal · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8436-1 | 63629843601 | 4 PACKET in 1 BOX (63629-8436-1) / 1 SUPPOSITORY in 1 PACKETMarketed from Jun 1, 2021 |
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)
- Belladonna and Opium
- Generic name (nonproprietary)
- atropa belladonna and opium
- Active ingredients
- Atropa belladonna — 16.2 mg/1Opium — 30 mg/1
- Dosage form
- Suppository
- Route
- Rectal
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- DEA schedule
- CII
- Identifiers
- Product ID 63629-8436_580cd487-06dc-4c1b-a312-0042f4e792e8SPL ID 580cd487-06dc-4c1b-a312-0042f4e792e8SPL set ID 088b9cd1-da68-4c34-8f09-62c2cde19e1fRxCUI 312104UNII WQZ3G9PF0H, 37M3MZ001L
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
N463629843601followed by a unit qualifier and the quantityPackage 63629-8436-01. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [ see Warnings and Precautions (5.1) ], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: • Have not been tolerated, or are not expected to be tolerated, • Have not provided adequate analgesia, or are not expected to provide adequate analgesic Belladonna and opium suppositories are an…
Excerpt only. Read the full label for complete information.