polycin
- Product NDC
- 53002-9270
- 11-digit product format
- 530029270
- Labeler code
- 53002
- Product ID
- 53002-9270_837c9f7c-b5bd-4e7c-9082-1bb5500c6ed3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bacitracin zinc and polymyxin b sulfates
- Dosage form
- OINTMENT
- Route
- OPHTHALMIC
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA065022
- Marketing category
- ANDA
- Marketing start
- 2014-11-12
- Marketing end
- 0000-00-00
- Substance
- BACITRACIN ZINC; POLYMYXIN B SULFATE
- Active strength
- 500 [USP'U]/g; [USP'U]/g
- Pharmacologic classes
- Decreased Cell Wall Synthesis & Repair [PE],Polymyxin-class Antibacterial [EPC],Polymyxins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|---|---|---|---|---|
| 53002-9270-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d1-2412-f424-e053-dadaa90a57ce | Polycin® bacitracin zinc and polymyxin B sulfate Ophthalmic Ointment USP STERILE Rx Only |
| 53002-9270-1 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d1-2412-f424-e053-dadaa90a57ce | Polycin® bacitracin zinc and polymyxin B sulfate Ophthalmic Ointment USP STERILE Rx Only |
| 53002-9270-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-2412-f424-e053-dadaa90a57ce | Polycin® bacitracin zinc and polymyxin B sulfate Ophthalmic Ointment USP STERILE Rx Only |
| 53002-9270-1 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d1-2412-f424-e053-dadaa90a57ce | Polycin® bacitracin zinc and polymyxin B sulfate Ophthalmic Ointment USP STERILE Rx Only |
| 53002-9270-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-2412-f424-e053-dadaa90a57ce | Polycin® bacitracin zinc and polymyxin B sulfate Ophthalmic Ointment USP STERILE Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-9270-1 | polycin | 3.5 g in 1 TUBE | OINTMENT | 3.5 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-9270 | POLYCIN (BACITRACIN ZINC AND POLYMYXIN B SULFATES) OINTMENT [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_8108496d-a5d0-45cc-bbbe-93d905bde167.zip |
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 | 8108496d-a5d0-45cc-bbbe-93d905bde167 | 5 |
| 213621 | Polycin 500 UNT/GM / 10,000 UNT/GM Ophthalmic Ointment | PSN | 8108496d-a5d0-45cc-bbbe-93d905bde167 | 5 |
| 213621 | bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment [Polycin] | SBD | 8108496d-a5d0-45cc-bbbe-93d905bde167 | 5 |
| 308511 | bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment | SCD | 8108496d-a5d0-45cc-bbbe-93d905bde167 | 5 |
| 308511 | bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic Ointment | SY | 8108496d-a5d0-45cc-bbbe-93d905bde167 | 5 |
| 213621 | Polycin-B (bacitracin 500 UNT/GM / polymyxin B 10,000 UNT/GM) Ophthalmic Ointment | SY | 8108496d-a5d0-45cc-bbbe-93d905bde167 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-9270-1 | 53002927001 | 3.5 g in 1 TUBE (53002-9270-1) | 3.5 g | 2018-10-01 | 0000-00-00 | No | No | Current |