Prescription drug · ANDA
Prednisone NDC 63187-300
Prednisone 10 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-300-05 | 6318703000563187030005 | 5 TABLET in 1 BOTTLE (63187-300-05)Marketed from May 2, 2016 | |
| 63187-300-06 | 6318703000663187030006 | 6 TABLET in 1 BOTTLE (63187-300-06)Marketed from May 2, 2016 | |
| 63187-300-08 | 6318703000863187030008 | 8 TABLET in 1 BOTTLE (63187-300-08)Marketed from May 2, 2016 | |
| 63187-300-09 | 6318703000963187030009 | 9 TABLET in 1 BOTTLE (63187-300-09)Marketed from May 2, 2016 | |
| 63187-300-10 | 6318703001063187030010 | 10 TABLET in 1 BOTTLE (63187-300-10)Marketed from May 2, 2016 | |
| 63187-300-12 | 6318703001263187030012 | 12 TABLET in 1 BOTTLE (63187-300-12)Marketed from May 2, 2016 | |
| 63187-300-15 | 6318703001563187030015 | 15 TABLET in 1 BOTTLE (63187-300-15)Marketed from May 2, 2016 | |
| 63187-300-18 | 6318703001863187030018 | 18 TABLET in 1 BOTTLE (63187-300-18)Marketed from Nov 1, 2017 | |
| 63187-300-20 | 6318703002063187030020 | 20 TABLET in 1 BOTTLE (63187-300-20)Marketed from May 2, 2016 | |
| 63187-300-21 | 6318703002163187030021 | 21 TABLET in 1 BOTTLE (63187-300-21)Marketed from May 2, 2016 | |
| 63187-300-24 | 6318703002463187030024 | 24 TABLET in 1 BOTTLE (63187-300-24)Marketed from May 2, 2016 | |
| 63187-300-27 | 6318703002763187030027 | 27 TABLET in 1 BOTTLE (63187-300-27)Marketed from Nov 1, 2017 | |
| 63187-300-28 | 6318703002863187030028 | 28 TABLET in 1 BOTTLE (63187-300-28)Marketed from Oct 1, 2019 | |
| 63187-300-30 | 6318703003063187030030 | 30 TABLET in 1 BOTTLE (63187-300-30)Marketed from May 2, 2016 | |
| 63187-300-36 | 6318703003663187030036 | 36 TABLET in 1 BOTTLE (63187-300-36)Marketed from Apr 3, 2017 | |
| 63187-300-40 | 6318703004063187030040 | 40 TABLET in 1 BOTTLE (63187-300-40)Marketed from May 2, 2016 | |
| 63187-300-42 | 6318703004263187030042 | 42 TABLET in 1 BOTTLE (63187-300-42)Marketed from May 2, 2016 |
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)
- Prednisone
- Generic name (nonproprietary)
- prednisone
- Active ingredients
- Prednisone — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040362
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63187-300_7a33b3c9-ca90-4d15-aacf-5a8f91b804a4SPL ID 7a33b3c9-ca90-4d15-aacf-5a8f91b804a4SPL set ID 5961b1d4-6a4c-452f-b3f1-c99f3a9a6445RxCUI 198145UNII VB0R961HZTUPC 0363187300425
- Pharmacologic class
- Corticosteroid
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N463187030005followed by a unit qualifier and the quantityPackage 63187-0300-05. 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 Prednisone Tablets, USP are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Nonsuppurative thyroiditis 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) …
Excerpt only. Read the full label for complete information.
About NDC 63187-300
- What is NDC 63187-300?
- 63187-300 is the product NDC for Prednisone, Prednisone 10 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 17 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prednisone.
- What is the active ingredient?
- Prednisone.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prednisone?
- 281 other product NDCs are listed under this name. See all Prednisone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prednisone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| PredniSONE | Prednisone 10 mg/1 | TabletOral | Coupler LLC | 67046-1294 | 67046-1294-03 |
| PredniSONE | Prednisone 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4182 | 68788-4182-0168788-4182-0268788-4182-03+3 more |
| prednisone | Prednisone 10 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-069 | 87441-0069-01 |
| prednisone | Prednisone 50 mg/1 | TabletOral | Coupler LLC | 67046-1171 | 67046-1171-03 |
| prednisone | Prednisone 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2582 | 55154-2582-00 |
| prednisone | Prednisone 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4660 | 70518-4660-00 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | Coupler LLC | 67046-1379 | 67046-1379-03 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2581 | 55154-2581-00 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4560 | 70518-4560-00 |
| prednisone | Prednisone 5 mg/1 | TabletOral | American Health Packaging | 60687-903 | 60687-0903-01 |
Other NDCs under ANDA 040362
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 |
|---|---|---|---|---|
| Prednisone | Prednisone 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-3137 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-3354 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-3361 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-5202 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7124 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Proficient Rx LP | 63187-020 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Proficient Rx LP | 63187-807 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-171 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-172 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-812 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-860 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3143 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-067 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-068 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-069 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0069 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0105 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0106 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0193 |