Over-the-counter drug · OTC MONOGRAPH DRUG
Calamine (Calamine 8% and zinc oxide 8%) NDC 82645-900
Zinc oxide 160 mg/mL · Lotion · Topical · Pharma Nobis, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)82645-900Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82645-0900Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82645-900-96 | 8264509009682645090096 | 177 mL in 1 BOTTLE, PLASTIC (82645-900-96)Marketed from Nov 13, 2017 |
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)
- Calamine
- Generic name (nonproprietary)
- calamine 8% and zinc oxide 8%
- Active ingredients
- Zinc oxide — 160 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Pharma Nobis, LLCNDC labeler code 82645
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 016
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Copper Ion Absorption (Physiologic effect)
- Identifiers
- Product ID 82645-900_0d1cd55e-cd93-6e7e-e063-6294a90ae7a5SPL ID 0d1cd55e-cd93-6e7e-e063-6294a90ae7a5SPL set ID e42f0bd6-3ad3-7e07-e053-2995a90a564aRxCUI 617954UNII SOI2LOH54ZUPC 0072036987235, 0087701400926, 0036800384323, 0681131176002, 0010939148339, 0084579118762, 0635515945074, 0015127009515, 0045591041964
- Pharmacologic class
- Copper Absorption Inhibitor
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
N482645090096followed by a unit qualifier and the quantityPackage 82645-0900-96. 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 dries the oozing and weeping o poison ivy, poison oak, and poison sumac.
Excerpt only. Read the full label for complete information.
About NDC 82645-900
- What is NDC 82645-900?
- 82645-900 is the product NDC for Calamine, Zinc oxide 160 mg/mL lotion, listed with the FDA by Pharma Nobis, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Calamine (Calamine 8% and Zinc Oxide 8%).
- What is the active ingredient?
- Zinc oxide.
- Who is the labeler?
- Pharma Nobis, LLC, NDC labeler code 82645. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Calamine?
- 30 other product NDCs are listed under this name. See all Calamine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Calamine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Calaminecalamine and zinc oxide | Zinc oxide 80 mg/mL; Ferric oxide red 80 mg/mL | LotionTopical | Marie's Original Formulas LLC | 87541-435 | 87541-0435-45 |
| Calaminecalamine and zinc oxide | Ferric oxide red 80 mg/mL; Zinc oxide 80 mg/mL | LotionTopical | Marie's Original Formulas LLC | 87541-632 | 87541-0632-72 |
| Calaminecalamine 8%, zinc oxide 8% | Ferric oxide red 80 mg/mL; Zinc oxide 80 mg/mL | LotionTopical | Farmacias De Similares TX LLC | 85786-703 | 85786-0703-06 |
| Calamine | Ferric oxide red 80 mg/100mL; Zinc oxide 80 mg/100mL | LotionTopical | AMERISOURCE BERGEN | 46122-809 | 46122-0809-29 |
| calaminecalamine and zinc oxide | Zinc oxide 160 mg/mL | LotionTopical | STRATEGIC SOURCING SERVICES | 70677-1316 | 70677-1316-01 |
| Calaminecalamine, pramoxine hcl | Ferric oxide red 80 mg/mL; Pramoxine hydrochloride 10 mg/mL | LotionTopical | Chain Drug Marketing Association | 83324-053 | 83324-0053-06 |
| Calamineferric oxide red | Ferric oxide red 80 mg/mL; Zinc oxide 80 mg/mL | LotionTopical | Chain Drug Marketing Association | 83324-248 | 83324-0248-06 |
| Calaminecalamine and zinc oxide | Ferric oxide red 80 mg/mL; Zinc oxide 80 mg/mL | LotionTopical | Strategic Sourcing Services, LLC | 70677-1196 | 70677-1196-01 |
| calaminecalamine and zinc oxide | Zinc oxide 160 mg/mL | LotionTopical | WALGREEN COMPANY | 0363-9410 | 00363-9410-97 |
| Calaminecalamine and zinc oxide | Ferric oxide red 80 mg/mL; Zinc oxide 80 mg/mL | LotionTopical | Pharma Nobis, LLC | 82645-418 | 82645-0418-96 |
Other NDCs under M 016
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 |
|---|---|---|---|---|
| 2-Pack Facial Serum | Water 78.894 g/100mL + 4 more ingredients | LiquidCutaneous | Guangzhou Ariel Biotech Co., Ltd. | 84148-011 |
| 2-Pack Facial Serum | 3-o-ethyl ascorbic acid .5 g/100mL + 3 more ingredients | LiquidCutaneous | Guangzhou Ariel Biotech Co., Ltd. | 84148-012 |
| 3M Cavilon Durable Barrierdimethicone | Dimethicone 13000 mg/L | CreamTopical | Solventum US LLC | 17518-030 |
| 4% 10gTATTOO Numb Cream4% lidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-031 |
| 4% TATTOO Numb Cream4% lidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-030 |
| 456 Acne Relief Creamniacinamide,salicylic acid,centella asiatica root,coptis chinensis root | Salicylic acid 380 mg/50g + 3 more ingredients | CreamTopical | Guangzhou Senmai Biotechnology Co.,Ltd. | 84509-111 |
| 5% Dr.care Numb creamlidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-028 |
| 5% Minoxidil | Minoxidil 2 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-328 |
| 5% Minoxidil | Minoxidil 2 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-329 |
| 5% Minoxidil | Biotin .05 g/100g; Niacinamide 2.5 g/100g | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-335 |
| 5% Minoxidil | Minoxidil 5 g/100g + 5 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-337 |
| 5% Minoxidil for Men and Women | Biotin .05 g/100g; Tocopherol .05 g/100g | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-332 |
| 5% Minoxidil Hair Growth | Biotin .1 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-333 |
| 5% Minoxidil Hair Growth | Minoxidil 5 g/100g + 3 more ingredients | SprayCutaneous | Guangzhou Yanxi Biotechnology Co., Ltd | 84025-334 |
| 5% Signature Numb creamlidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-026 |
| 5% Signature Numb cream5% signature | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-027 |
| 5% Signature Numb cream5% lidocaine | Lidocaine 100 mg/g | CreamCutaneous | Shengnan (Guangzhou) Cosmetics Co., LTD | 84019-029 |
| 70% Isopropyl Rubbing Alcoholisopropyl alcohol | Isopropyl alcohol 70 mL/100mL | LiquidTopical | MY IMPORTS USA LLC | 51628-4501 |
| 911allantoin | Allantoin .5 g/100g | OintmentTopical | Skinfix, Inc. | 61328-120 |
| A and Dpetrolatum | Petrolatum 76 g/100g | OintmentTopical | Safetec of America, Inc. | 61010-4405 |
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