Isoniazid
- Product NDC
- 53808-1041
- 11-digit product format
- 538081041
- Labeler code
- 53808
- Product ID
- 53808-1041_2a74eb4a-6f94-4b7a-9234-8fc9339d7b6a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isoniazid
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- State of Florida DOH Central Pharmacy
- Application
- ANDA080937
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- Marketing end
- 0000-00-00
- Substance
- ISONIAZID
- Active strength
- 300 mg/1
- Pharmacologic classes
- Antimycobacterial [EPC]
- 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 |
|---|---|---|---|
| 0c158ae5-31fa-5bc4-3cf2-0aa120f1417d | Product name | 1 | 20140508 |
| 26abd97e-907b-0cb8-84ee-99fb15297ada | Product name | 1 | 20140508 |
| 7cf7f62d-3767-728f-c117-96e96c1ed8bf | Product name | 1 | 20140508 |
| 9e3dea0d-7fd5-1a7e-e095-3b9e72f40538 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53808-1041-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e198-f424-e053-dadaa90a57ce | ISONIAZID TABLETS, USP 100 mg and 300 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53808-1041-1 | Isoniazid | 30 in 1 BLISTER PACK | TABLET | 30 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ISONIAZID | ACTIVE INGREDIENT | V83O1VOZ8L | ISONIAZID TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| ISONIAZID | ACTIVE MOIETY | V83O1VOZ8L | ISONIAZID TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ISONIAZID TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ISONIAZID TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | ISONIAZID TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ISONIAZID TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | ISONIAZID TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53808-1041 | ISONIAZID TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | Legacy NDC, 1 package rows | 20141007_fdc162f2-67c5-4e36-9832-cf48e05b6ed1.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197832 | isoniazid 300 MG Oral Tablet | PSN | fdc162f2-67c5-4e36-9832-cf48e05b6ed1 | 1 |
| 197832 | isoniazid 300 MG Oral Tablet | SCD | fdc162f2-67c5-4e36-9832-cf48e05b6ed1 | 1 |
| 197832 | INH 300 MG Oral Tablet | SY | fdc162f2-67c5-4e36-9832-cf48e05b6ed1 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53808-1041-1 | 53808104101 | 30 in 1 BLISTER PACK | Historical |