Bacitracin Zinc and Polymyxin B Sulfate
- Product NDC
- 42254-154
- 11-digit product format
- 422540154
- Labeler code
- 42254
- Product ID
- 42254-154_c6c69fa4-d7be-4c09-b7fa-53c40fad78a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bacitracin Zinc and Polymyxin B Sulfate
- Dosage form
- OINTMENT
- Route
- OPHTHALMIC
- Labeler
- Rebel Distributors Corp
- Application
- ANDA064046
- Marketing category
- ANDA
- Marketing start
- 2008-04-25
- Marketing end
- 0000-00-00
- Substance
- BACITRACIN ZINC; POLYMYXIN B SULFATE
- Active strength
- 500 1/g; 1/g
- Pharmacologic classes
- Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c | Product name | 1 | 20160603 |
| 2d352c73-a357-4193-a4de-dfdf9a2ac8e4 | Product name | 1 | 20150819 |
| b045ad64-0f28-9a02-2f9b-b34d94fb2278 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42254-154-35 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3d82-c013-e053-90daa90a1393 | Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP (Sterile) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42254-154-35 | Bacitracin Zinc and Polymyxin B Sulfate | 3.5 g in 1 TUBE | OINTMENT | 3.5 | 1 | |
| 42254-154-35 | Bacitracin Zinc and Polymyxin B Sulfate | 1 in 1 CARTON | OINTMENT | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42254-154-35 | GM - Gram | 42254-154 | a70d65b2-6b02-4039-be0a-42f7347dcbfd | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BACITRACIN ZINC | ACTIVE INGREDIENT | 89Y4M234ES | BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYMYXIN B SULFATE | ACTIVE INGREDIENT | 19371312D4 | BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| BACITRACIN | ACTIVE MOIETY | 58H6RWO52I | BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYMYXIN B | ACTIVE MOIETY | J2VZ07J96K | BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308511 | bacitracin zinc 500 UNT / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment | PSN | c6c69fa4-d7be-4c09-b7fa-53c40fad78a7 | 1 |
| 308511 | bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment | SCD | c6c69fa4-d7be-4c09-b7fa-53c40fad78a7 | 1 |
| 308511 | bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic Ointment | SY | c6c69fa4-d7be-4c09-b7fa-53c40fad78a7 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 42254-154-35 | 42254015435 | 3.5 g in 1 TUBE | 3.5 g | Historical |