Prescription drug · UNAPPROVED DRUG OTHER
Hyoscyamine Sulfate NDC 54288-111
Hyoscyamine sulfate .5 mg/mL · Injection, Solution · Subcutaneous · BPI Labs LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54288-111-05 | 5428801110554288011105 | 5 VIAL in 1 CARTON (54288-111-05) / 1 mL in 1 VIAL (54288-111-01)Marketed from Oct 18, 2019 |
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)
- Hyoscyamine Sulfate
- Generic name (nonproprietary)
- hyoscyamine sulfate
- Active ingredients
- Hyoscyamine sulfate — .5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- BPI Labs LLCNDC labeler code 54288
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Identifiers
- Product ID 54288-111_ba3bb8f4-5954-40a8-a072-2f75edb2c102SPL ID ba3bb8f4-5954-40a8-a072-2f75edb2c102SPL set ID 6c0a1fef-c634-4ecf-9850-d188e6496b90RxCUI 1047916UNII F2R8V82B84
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
N454288011105followed by a unit qualifier and the quantityPackage 54288-0111-05. 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 Hyoscyamine sulfate Injection, USP is effective as adjunctive therapy in the treatment of peptic ulcer. In acute episodes, Hyoscyamine sulfate Injection, USP can be used to control gastric secretion, visceral spasm and hypermotility in spastic colitis, spastic bladder, cystitis, pylorospasm, and associated abdominal cramps. For use as adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and functional gastrointestinal disorders. Also as adjunctive therapy in the treatment of neurogenic bladder and neurogenic bowel disturbances (including the splenic flexure syndrome and neurogenic colon). Parenterally administe…
Excerpt only. Read the full label for complete information.
About NDC 54288-111
- What is NDC 54288-111?
- 54288-111 is the product NDC for Hyoscyamine Sulfate, Hyoscyamine sulfate .5 mg/mL injection, solution, listed with the FDA by BPI Labs LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hyoscyamine Sulfate.
- What is the active ingredient?
- Hyoscyamine sulfate.
- Who is the labeler?
- BPI Labs LLC, NDC labeler code 54288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hyoscyamine Sulfate?
- 28 other product NDCs are listed under this name. See all Hyoscyamine Sulfate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hyoscyamine Sulfate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hyoscyamine Sulfate | Hyoscyamine sulfate .125 mg/1 | TabletOral | Granulation Technology, Inc. | 63561-0203 | 63561-0203-01 |
| Hyoscyamine Sulfate | Hyoscyamine sulfate .125 mg/1 | Tablet, Orally disintegratingOral | Granulation Technology, Inc. | 63561-0197 | 63561-0197-01 |
| Hyoscyamine Sulfate | Hyoscyamine sulfate .125 mg/1 | Tablet, Orally disintegratingOral | PD-Rx Pharmaceuticals, Inc. | 72789-563 | 72789-0563-01 |
| Hyoscyamine Sulfate | Hyoscyamine sulfate .125 mg/1 | TabletSublingual | Granulation Technology, Inc. | 63561-0202 | 63561-0202-01 |
| Hyoscyamine Sulfate | Hyoscyamine sulfate .125 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4436 | 70518-4436-00 |
| Hyoscyamine Sulfate | Hyoscyamine sulfate .125 mg/1 | TabletOral | Westminster Pharmaceuticals, LLC | 69367-677 | 69367-0677-01 |
| Hyoscyamine Sulfate | Hyoscyamine sulfate .125 mg/1 | TabletOral | Proficient Rx LP | 82804-965 | 82804-0965-3082804-0965-6082804-0965-64+3 more |
| Hyoscyamine sulfate | Hyoscyamine sulfate .125 mg/1 | Tablet, Orally disintegratingOral | Chartwell RX, LLC | 62135-858 | 62135-0858-12 |
| Hyoscyamine Sulfate | Hyoscyamine sulfate .375 mg/1 | Tablet, Extended releaseOral | Patrin Pharma, Inc. | 39328-052 | 39328-0052-10 |
| Hyoscyamine Sulfate | Hyoscyamine sulfate .125 mg/1 | Tablet, Orally disintegratingOral | Patrin Pharma, Inc. | 39328-049 | 39328-0049-10 |