Prednisone
- Product NDC
- 21695-306
- 11-digit product format
- 216950306
- Labeler code
- 21695
- Product ID
- 21695-306_9fde9268-d5e8-4402-a429-df55f075861d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA088832
- Marketing category
- ANDA
- Marketing start
- 1985-12-04
- Marketing end
- 0000-00-00
- Substance
- PREDNISONE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2205d503-be51-445b-bb34-c209cc557b3c | Product name | 5 | 20230105 |
| 9492a99d-61c8-491f-9086-1c6a7e98c040 | Product name | 6 | 20230105 |
| 205c2cdd-a63b-cbc9-6bcb-6be6001edf81 | Product name | 2 | 20170705 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-306-20 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4cfb-48b1-e053-8cdaa90a720a | PREDNISONE TABLETS |
| 21695-306-21 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4cfb-48b1-e053-8cdaa90a720a | PREDNISONE TABLETS |
| 21695-306-28 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4cfb-48b1-e053-8cdaa90a720a | PREDNISONE TABLETS |
| 21695-306-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4cfb-48b1-e053-8cdaa90a720a | PREDNISONE TABLETS |
| 21695-306-36 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4cfb-48b1-e053-8cdaa90a720a | PREDNISONE TABLETS |
| 21695-306-39 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4cfb-48b1-e053-8cdaa90a720a | PREDNISONE TABLETS |
| 21695-306-42 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4cfb-48b1-e053-8cdaa90a720a | PREDNISONE TABLETS |
| 21695-306-50 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4cfb-48b1-e053-8cdaa90a720a | PREDNISONE TABLETS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-306-20 | Prednisone | 20 in 1 BOTTLE | TABLET | 20 | 1 | |
| 21695-306-21 | Prednisone | 21 in 1 BOTTLE | TABLET | 21 | 1 | |
| 21695-306-28 | Prednisone | 28 in 1 BOTTLE | TABLET | 28 | 1 | |
| 21695-306-30 | Prednisone | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 21695-306-36 | Prednisone | 36 in 1 BOTTLE | TABLET | 36 | 1 | |
| 21695-306-39 | Prednisone | 39 in 1 BOTTLE | TABLET | 39 | 1 | |
| 21695-306-42 | Prednisone | 42 in 1 BOTTLE | TABLET | 42 | 1 | |
| 21695-306-50 | Prednisone | 50 in 1 BOTTLE | TABLET | 50 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-306-20 | EA - Each | 21695-306 | d68c6006-b970-4240-821f-aaeb05a39c85 | 1 | 2012-07-24 |
| 21695-306-21 | EA - Each | 21695-306 | a5891b11-2372-45ea-855f-5f7298074519 | 1 | 2012-07-24 |
| 21695-306-28 | EA - Each | 21695-306 | f223fc49-7088-4330-9ef0-8cc6124530ed | 1 | 2012-07-24 |
| 21695-306-30 | EA - Each | 21695-306 | 97330d2e-bb5d-4399-9711-ef6dda52e65b | 1 | 2012-07-24 |
| 21695-306-36 | EA - Each | 21695-306 | ebe5ea56-7d56-46f8-8b40-7c5731f1a581 | 1 | 2012-07-24 |
| 21695-306-39 | EA - Each | 21695-306 | a94394bb-d07b-453c-9ad5-7aae3d89a78e | 1 | 2012-07-24 |
| 21695-306-42 | EA - Each | 21695-306 | ab57eca8-c95d-4ed1-8d07-339a32b2ca44 | 1 | 2012-07-24 |
| 21695-306-50 | EA - Each | 21695-306 | 33e3e8dc-05d6-40ac-91b5-3e49f07b5fcc | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Prednisone | ACTIVE INGREDIENT | VB0R961HZT | PREDNISONE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| Prednisone | ACTIVE MOIETY | VB0R961HZT | PREDNISONE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | PREDNISONE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | PREDNISONE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | PREDNISONE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | PREDNISONE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| Magnesium Stearate | INACTIVE INGREDIENT | 70097M6I30 | PREDNISONE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | PREDNISONE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | PREDNISONE TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | PREDNISONE TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198145 | predniSONE 10 MG Oral Tablet | PSN | 9fde9268-d5e8-4402-a429-df55f075861d | 1 |
| 312615 | predniSONE 20 MG Oral Tablet | PSN | 9fde9268-d5e8-4402-a429-df55f075861d | 1 |
| 312617 | predniSONE 5 MG Oral Tablet | PSN | 9fde9268-d5e8-4402-a429-df55f075861d | 1 |
| 198145 | prednisone 10 MG Oral Tablet | SCD | 9fde9268-d5e8-4402-a429-df55f075861d | 1 |
| 312615 | prednisone 20 MG Oral Tablet | SCD | 9fde9268-d5e8-4402-a429-df55f075861d | 1 |
| 312617 | prednisone 5 MG Oral Tablet | SCD | 9fde9268-d5e8-4402-a429-df55f075861d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-306-20 | 21695030620 | 20 in 1 BOTTLE | Historical |
| 21695-306-21 | 21695030621 | 21 in 1 BOTTLE | Historical |
| 21695-306-28 | 21695030628 | 28 in 1 BOTTLE | Historical |
| 21695-306-30 | 21695030630 | 30 in 1 BOTTLE | Historical |
| 21695-306-36 | 21695030636 | 36 in 1 BOTTLE | Historical |
| 21695-306-39 | 21695030639 | 39 in 1 BOTTLE | Historical |
| 21695-306-42 | 21695030642 | 42 in 1 BOTTLE | Historical |
| 21695-306-50 | 21695030650 | 50 in 1 BOTTLE | Historical |