Isoniazid
- Product NDC
- 61748-016
- 11-digit product format
- 617480016
- Labeler code
- 61748
- Product ID
- 61748-016_1247f0c8-25be-49b0-96e1-22b1cf50dc00
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isoniazid
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- VersaPharm Incorporated
- Application
- ANDA080212
- Marketing category
- ANDA
- Marketing start
- 1997-09-01
- Marketing end
- 0000-00-00
- Substance
- ISONIAZID
- Active strength
- 100 mg/1
- Pharmacologic classes
- Antimycobacterial [EPC]
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- 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 |
|---|---|---|---|---|---|
| 61748-016-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-009c-f424-e053-dadaa90a57ce | ISONIAZID TABLETS, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61748-016-01 | Isoniazid | 100 in 1 BOTTLE | TABLET | 100 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ISONIAZID | ACTIVE INGREDIENT | V83O1VOZ8L | ISONIAZID TABLET [VERSAPHARM INCORPORATED] | 1 | |
| ISONIAZID | ACTIVE MOIETY | V83O1VOZ8L | ISONIAZID TABLET [VERSAPHARM INCORPORATED] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | ISONIAZID TABLET [VERSAPHARM INCORPORATED] | 1 | |
| CALCIUM STEARATE | INACTIVE INGREDIENT | 776XM7047L | ISONIAZID TABLET [VERSAPHARM INCORPORATED] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ISONIAZID TABLET [VERSAPHARM INCORPORATED] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | ISONIAZID TABLET [VERSAPHARM INCORPORATED] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ISONIAZID TABLET [VERSAPHARM INCORPORATED] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311166 | isoniazid 100 MG Oral Tablet | PSN | 1247f0c8-25be-49b0-96e1-22b1cf50dc00 | 1 |
| 197832 | isoniazid 300 MG Oral Tablet | PSN | 1247f0c8-25be-49b0-96e1-22b1cf50dc00 | 1 |
| 311166 | isoniazid 100 MG Oral Tablet | SCD | 1247f0c8-25be-49b0-96e1-22b1cf50dc00 | 1 |
| 197832 | isoniazid 300 MG Oral Tablet | SCD | 1247f0c8-25be-49b0-96e1-22b1cf50dc00 | 1 |
| 311166 | INH 100 MG Oral Tablet | SY | 1247f0c8-25be-49b0-96e1-22b1cf50dc00 | 1 |
| 197832 | INH 300 MG Oral Tablet | SY | 1247f0c8-25be-49b0-96e1-22b1cf50dc00 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 61748-016-01 | 61748001601 | 100 in 1 BOTTLE | Historical |