Prescription drug · NDA
Betasept (Antiseptic surgical scrub) NDC 0116-0200
Chlorhexidine gluconate .04 mg/mL · Solution · Topical · Xttrium Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0116-0200-01 | 0011602000100116020001 | 3785 mL in 1 BOTTLE (0116-0200-01)Marketed from Jun 1, 1993 | |
| 0116-0200-04 | 0011602000400116020004 | 118 mL in 1 BOTTLE (0116-0200-04)Marketed from Jun 1, 1993 | |
| 0116-0200-08 | 0011602000800116020008 | 237 mL in 1 BOTTLE (0116-0200-08)Marketed from Jun 1, 1993 | |
| 0116-0200-16 | 0011602001600116020016 | 473 mL in 1 BOTTLE (0116-0200-16)Marketed from Jun 1, 1993 | |
| 0116-0200-30 | 0011602003000116020030 | 946 mL in 1 BOTTLE (0116-0200-30)Marketed from Jun 1, 1993 | |
| 0116-0200-32 | 0011602003200116020032 | 946 mL in 1 BOTTLE (0116-0200-32)Marketed from Jun 1, 1993 |
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)
- Betasept
- Generic name (nonproprietary)
- antiseptic surgical scrub
- Active ingredients
- Chlorhexidine gluconate — .04 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Xttrium Laboratories, Inc.NDC labeler code 0116
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019125
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 0116-0200_34007201-2d77-96fd-e063-6394a90a6327SPL ID 34007201-2d77-96fd-e063-6394a90a6327SPL set ID 4a6451d7-b347-37ac-e054-00144ff8d46cRxCUI 211365, 834150UNII MOR84MUD8EUPC 0367618200087, 0367618200049
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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400116020001followed by a unit qualifier and the quantityPackage 00116-0200-01. 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 .
Indications (excerpt from the label)
Uses surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care healthcare personnel handwash: helps reduce bacteria that potentially can cause disease patient preoperative skin preparation: preparation of the patient's skin prior to surgery skin wound and general skin cleansing
Excerpt only. Read the full label for complete information.
About NDC 0116-0200
- What is NDC 0116-0200?
- 0116-0200 is the product NDC for Betasept (antiseptic surgical scrub), Chlorhexidine gluconate .04 mg/mL solution, listed with the FDA by Xttrium Laboratories, Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Betasept (Antiseptic Surgical Scrub).
- What is the active ingredient?
- Chlorhexidine gluconate.
- Who is the labeler?
- Xttrium Laboratories, Inc., NDC labeler code 0116. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Betasept?
- 1 other product NDC are listed under this name. See all Betasept NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Betasept products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Betaseptantiseptic surgical scrub | Chlorhexidine gluconate .04 mg/mL | SolutionTopical | Atlantis Consumer Healthcare, Inc. | 67618-200 | 67618-0200-0467618-0200-0867618-0200-16+1 more |
Other NDCs under NDA 019125
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 |
|---|---|---|---|---|
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | AmerisourceBergen Drug Corporation | 46122-137 |
| Foster and Thrivechlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | McKesson Corporation | 70677-1221 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Chain Drug Marketing Association Inc. | 63868-940 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-3678 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-0137 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-0161 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-0401 |
| CliniCleanchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | HR Pharmaceuticals, Inc. | 69464-901 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0407 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Rite Aid | 11822-0891 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-0767 |
| Antiseptic Solutionchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Coloplast Corp | 11701-172 |
| CliniCleanchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-0901 |
| Betaseptantiseptic surgical scrub | Chlorhexidine gluconate .04 mg/mL | SolutionTopical | Atlantis Consumer Healthcare, Inc. | 67618-200 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | McKesson Medical-Surgical | 68599-5401 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 g/100mL | LiquidTopical | CVS Pharmacy, Inc. | 59779-767 |
| Antiseptic Skin Cleanserchlorhexidine gluconate 4% | Chlorhexidine gluconate 4 mg/100mL | LiquidTopical | Topco Associates LLC | 36800-401 |
| Dyna-Hex 4chlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | LiquidTopical | Xttrium Laboratories, Inc. | 0116-1060 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-1061 |
| Antiseptic Skin Cleanserchlorhexidine gluconate | Chlorhexidine gluconate 4 g/100mL | SolutionTopical | Xttrium Laboratories, Inc. | 0116-1061 |
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