BCG VACCINE
- Product NDC
- 0052-0603
- 11-digit product format
- 000520603
- Labeler code
- 0052
- Product ID
- 0052-0603_2080f9b5-aac4-4fd1-b8aa-a7862fe28947
- Type
- VACCINE
- Nonproprietary name
- BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- PERCUTANEOUS
- Labeler
- Merck Sharp & Dohme LLC
- Application
- BLA103050
- Marketing category
- BLA
- Marketing start
- 1989-06-21
- Substance
- BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN
- Active strength
- 50 mg/1
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BCG VACCINE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN | 50 mg/1 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0052-0603-01 | BCG VACCINE | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 20 |
| 0052-0603-02 | BCG VACCINE | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 20 |
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 | BCG VACCINE (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ORGANON USA INC.] | 9 | |
| BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN | ACTIVE MOIETY | 2XQ558L16Z | BCG VACCINE (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ORGANON USA INC.] | 9 | |
| asparagine | INACTIVE INGREDIENT | 5Z33R5TKO7 | BCG VACCINE (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ORGANON USA INC.] | 9 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | BCG VACCINE (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ORGANON USA INC.] | 9 | |
| ferric ammonium citrate | INACTIVE INGREDIENT | UVP74NG1C5 | BCG VACCINE (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ORGANON USA INC.] | 9 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | BCG VACCINE (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ORGANON USA INC.] | 9 | |
| lactose | INACTIVE INGREDIENT | J2B2A4N98G | BCG VACCINE (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ORGANON USA INC.] | 9 | |
| magnesium sulfate | INACTIVE INGREDIENT | DE08037SAB | BCG VACCINE (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ORGANON USA INC.] | 9 | |
| potassium phosphate, unspecified form | INACTIVE INGREDIENT | B7862WZ632 | BCG VACCINE (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ORGANON USA INC.] | 9 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | BCG VACCINE (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ORGANON USA INC.] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0052-0603 | BCG VACCINE (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC] | 19 | Current NDC, Legacy NDC, 2 package rows | 20241019_a83f0b99-9038-4c5a-aaac-8792b32838fe.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 |
|---|
| 0052-0603-01 | 00052060301 | 1 in 1 VIAL | | | | | | Historical |
| 0052-0603-02 | 00052060302 | 1 VIAL in 1 CARTON (0052-0603-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0052-0603-01) | 1 vial | 1989-06-21 | 0000-00-00 | No | No | Current |