Prednisone
- Product NDC
- 21695-307
- 11-digit product format
- 216950307
- Labeler code
- 21695
- Product ID
- 21695-307_9fde9268-d5e8-4402-a429-df55f075861d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Prednisone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA083677
- Marketing category
- ANDA
- Marketing start
- 1974-02-26
- Marketing end
- 0000-00-00
- Substance
- PREDNISONE
- Active strength
- 20 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 |
|---|---|---|---|---|---|
| 21695-307-10 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4cfb-48b1-e053-8cdaa90a720a | PREDNISONE TABLETS |
| 21695-307-12 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4cfb-48b1-e053-8cdaa90a720a | PREDNISONE TABLETS |
| 21695-307-14 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4cfb-48b1-e053-8cdaa90a720a | PREDNISONE TABLETS |
| 21695-307-15 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4cfb-48b1-e053-8cdaa90a720a | PREDNISONE TABLETS |
| 21695-307-20 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4cfb-48b1-e053-8cdaa90a720a | PREDNISONE TABLETS |
| 21695-307-21 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4cfb-48b1-e053-8cdaa90a720a | PREDNISONE TABLETS |
| 21695-307-30 | 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 |
|---|---|---|---|---|---|---|
| 21695-307-10 | Prednisone | 10 in 1 BOTTLE | TABLET | 10 | 1 | |
| 21695-307-12 | Prednisone | 12 in 1 BOTTLE | TABLET | 12 | 1 | |
| 21695-307-14 | Prednisone | 14 in 1 BOTTLE | TABLET | 14 | 1 | |
| 21695-307-15 | Prednisone | 15 in 1 BOTTLE | TABLET | 15 | 1 | |
| 21695-307-20 | Prednisone | 20 in 1 BOTTLE | TABLET | 20 | 1 | |
| 21695-307-21 | Prednisone | 21 in 1 BOTTLE | TABLET | 21 | 1 | |
| 21695-307-30 | Prednisone | 30 in 1 BOTTLE | TABLET | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-307-10 | EA - Each | 21695-307 | 2b1b5e4e-33b6-4bfa-a74e-1a70da8af82f | 1 | 2012-07-24 |
| 21695-307-12 | EA - Each | 21695-307 | d03b0ef9-df19-44e6-a010-57a4974340f0 | 1 | 2012-07-24 |
| 21695-307-14 | EA - Each | 21695-307 | c56c431f-6b6c-422e-823c-8cd2d607c930 | 1 | 2012-07-24 |
| 21695-307-15 | EA - Each | 21695-307 | 34ee989b-064b-4f3c-8815-47eb44d8c333 | 1 | 2012-07-24 |
| 21695-307-20 | EA - Each | 21695-307 | b07b1b97-e936-4d8f-8f7e-d9aafcc87ce0 | 1 | 2012-07-24 |
| 21695-307-21 | EA - Each | 21695-307 | 774b6418-107a-4a97-81fa-3d23dbd1e673 | 1 | 2012-07-24 |
| 21695-307-30 | EA - Each | 21695-307 | fd3b1a6e-9988-4eb6-889f-085d62d58f11 | 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 |
|---|---|---|---|
| 21695-307-10 | 21695030710 | 10 in 1 BOTTLE | Historical |
| 21695-307-12 | 21695030712 | 12 in 1 BOTTLE | Historical |
| 21695-307-14 | 21695030714 | 14 in 1 BOTTLE | Historical |
| 21695-307-15 | 21695030715 | 15 in 1 BOTTLE | Historical |
| 21695-307-20 | 21695030720 | 20 in 1 BOTTLE | Historical |
| 21695-307-21 | 21695030721 | 21 in 1 BOTTLE | Historical |
| 21695-307-30 | 21695030730 | 30 in 1 BOTTLE | Historical |