CAPTOPRIL
- Product NDC
- 53217-003
- 11-digit product format
- 532170003
- Labeler code
- 53217
- Product ID
- 53217-003_d8132b9b-3eb6-4b19-a8cc-4a67712e19d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CAPTOPRIL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA074532
- Marketing category
- ANDA
- Marketing start
- 1997-03-28
- Marketing end
- 0000-00-00
- Substance
- CAPTOPRIL
- Active strength
- 13 mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d5efca61-58ec-b4d0-77f8-f2b1fb112156 | Product name | 4 | 20240223 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53217-003-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-fa99-f424-e053-dadaa90a57ce | CAPTOPRIL TABLETS, USP |
| 53217-003-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-fa99-f424-e053-dadaa90a57ce | CAPTOPRIL TABLETS, USP |
| 53217-003-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-fa99-f424-e053-dadaa90a57ce | CAPTOPRIL TABLETS, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53217-003-30 | CAPTOPRIL | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 1 | |
| 53217-003-60 | CAPTOPRIL | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | 1 | |
| 53217-003-90 | CAPTOPRIL | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53217-003-30 | EA - Each | 53217-003 | 7acecddc-2134-4fc5-85ae-edd758822aa3 | 1 | 2015-10-02 |
| 53217-003-60 | EA - Each | 53217-003 | 8b41ecc9-b74c-466d-8791-01a4e31c30e8 | 1 | 2015-10-02 |
| 53217-003-90 | EA - Each | 53217-003 | 914e90bc-4c40-4911-a194-59815c0d644e | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CAPTOPRIL | ACTIVE INGREDIENT | 9G64RSX1XD | CAPTOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CAPTOPRIL | ACTIVE MOIETY | 9G64RSX1XD | CAPTOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | CAPTOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | CAPTOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| PALMITIC ACID | INACTIVE INGREDIENT | 2V16EO95H1 | CAPTOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | CAPTOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | CAPTOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | CAPTOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308963 | captopril 12.5 MG Oral Tablet | PSN | 137ac94a-2461-4b33-9221-5ca80ed7a417 | 1 |
| 308963 | captopril 12.5 MG Oral Tablet | SCD | 137ac94a-2461-4b33-9221-5ca80ed7a417 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53217-003-30 | 53217000330 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 53217-003-60 | 53217000360 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 53217-003-90 | 53217000390 | 90 in 1 BOTTLE, PLASTIC | Historical |