TICE BCG
- Product NDC
- 0052-0602
- 11-digit product format
- 000520602
- Labeler code
- 0052
- Product ID
- 0052-0602_223f2b2b-87d0-4beb-b00a-16a2b041a5bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BACILLUS CALMETTE-GUERIN
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- INTRAVESICAL
- Labeler
- Merck Sharp & Dohme LLC
- Application
- BLA102821
- Marketing category
- BLA
- Marketing start
- 1990-08-24
- Substance
- BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN
- Active strength
- 50 mg/50mL
- Pharmacologic classes
- Actively Acquired Immunity [PE], BCG Vaccine [CS], Increased Immunologically Active Molecule Activity [PE], Increased Macrophage Proliferation [PE], Live Attenuated Bacillus Calmette-Guerin Immunotherapy [EPC], Live Attenuated Bacillus Calmette-Guerin Vaccine [EPC], Vaccines, Attenuated [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TICE BCG
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN | 50 mg/50mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2XQ558L16Z |
| Rxcui | 213744, 1653484 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0052-0602-01 | TICE BCG | 50 mL in 1 VIAL | POWDER, FOR SUSPENSION | 50 | | 22 |
| 0052-0602-02 | TICE BCG | 1 in 1 CARTON | POWDER, FOR SUSPENSION | 1 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN | ACTIVE INGREDIENT | 2XQ558L16Z | TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.] | 4 | |
| BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN | ACTIVE MOIETY | 2XQ558L16Z | TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.] | 4 | |
| ASPARAGINE | INACTIVE INGREDIENT | 5Z33R5TKO7 | TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.] | 4 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.] | 4 | |
| FERRIC AMMONIUM CITRATE | INACTIVE INGREDIENT | UVP74NG1C5 | TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.] | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.] | 4 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.] | 4 | |
| MAGNESIUM SULFATE | INACTIVE INGREDIENT | DE08037SAB | TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.] | 4 | |
| POTASSIUM PHOSPHATE, UNSPECIFIED FORM | INACTIVE INGREDIENT | B7862WZ632 | TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0052-0602 | TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [MERCK SHARP & DOHME LLC] | 20 | Current NDC, Legacy NDC, 2 package rows | 20241121_c9b74876-e665-442b-87ad-b7333bc9a67a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0052-0602-01 | 00052060201 | 50 mL in 1 VIAL | 50 ml | | | | | Historical |
| 0052-0602-02 | 00052060202 | 1 VIAL in 1 CARTON (0052-0602-02) / 50 mL in 1 VIAL (0052-0602-01) | 1 vial | 1990-08-24 | 0000-00-00 | No | No | Current |