Prescription drug · UNAPPROVED DRUG OTHER
Belladonna and Opium (Atropa belladonna and opium) NDC 0574-7045
Atropa belladonna 16.2 mg/1; Opium 30 mg/1 · Suppository · Rectal · Padagis US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0574-7045-04 | 0057470450400574704504 | 4 PACKET in 1 BOX (0574-7045-04) / 1 SUPPOSITORY in 1 PACKETMarketed from Aug 22, 2018 | |
| 0574-7045-12 | 0057470451200574704512 | 12 PACKET in 1 BOX (0574-7045-12) / 1 SUPPOSITORY in 1 PACKETMarketed from May 1, 1994 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- 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
- Padagis US LLCNDC labeler code 0574
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- DEA schedule
- CII
- Identifiers
- Product ID 0574-7045_7b45a1d7-c3a5-4434-a848-45638cedd6e1SPL ID 7b45a1d7-c3a5-4434-a848-45638cedd6e1SPL set ID 8301e76b-134a-43d2-a7dc-c600ccf2695cRxCUI 312104, 312107UNII 37M3MZ001L, WQZ3G9PF0H
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
N400574704504followed by a unit qualifier and the quantityPackage 00574-7045-04. 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 analgesia Belladonna and opium suppositories are a…
Excerpt only. Read the full label for complete information.
About NDC 0574-7045
- What is NDC 0574-7045?
- 0574-7045 is the product NDC for Belladonna and Opium, Atropa belladonna 16.2 mg/1; Opium 30 mg/1 suppository, listed with the FDA by Padagis US LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Belladonna and Opium (ATROPA BELLADONNA and OPIUM).
- What is the active ingredient?
- Atropa belladonna, Opium.
- Who is the labeler?
- Padagis US LLC, NDC labeler code 0574. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Belladonna and Opium?
- 2 other product NDCs are listed under this name. See all Belladonna and Opium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Belladonna and Opium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Belladonna and Opiumatropa belladonna and opium | Atropa belladonna 16.2 mg/1; Opium 60 mg/1 | SuppositoryRectal | Padagis US LLC | 0574-7040 | 00574-7040-0400574-7040-12 |
| Belladonna and Opiumatropa belladonna and opium | Atropa belladonna 16.2 mg/1; Opium 30 mg/1 | SuppositoryRectal | Bryant Ranch Prepack | 63629-8436 | 63629-8436-01 |