Erythromycin
- Product NDC
- 53002-9050
- 11-digit product format
- 530029050
- Labeler code
- 53002
- Product ID
- 53002-9050_eac92fa7-f567-449a-8f11-f8b0b8908f8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Erythromycin
- Dosage form
- OINTMENT
- Route
- OPHTHALMIC
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA064067
- Marketing category
- ANDA
- Marketing start
- 1994-07-29
- Marketing end
- 0000-00-00
- Substance
- ERYTHROMYCIN
- Active strength
- 5 mg/g
- Pharmacologic classes
- Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [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 |
|---|---|---|---|
| d329c2e1-5ae8-4e64-aea0-77ecea3fa1ab | Product name | 3 | 20250717 |
| 3b331500-3b74-bd2b-fede-d46839f2f4d5 | Product name | 6 | 20240313 |
| fdae2630-eae0-4769-abfd-8f33d5b771b4 | Product name | 3 | 20240202 |
| 8c898317-b543-1e4e-254f-84cec2f3f57e | Product name | 2 | 20191002 |
| 64ae94c0-3212-d73a-92da-9e6dd85c6ebe | Product name | 2 | 20180118 |
| edcfa1cf-915f-1a4c-d0aa-508cc66e70d9 | Product name | 2 | 20170816 |
| ad75fcfd-a339-42a1-9c60-43ba2c654cfa | Product name | 1 | 20170810 |
| 57850177-5927-151f-e1fa-7e2ca47f81e5 | Product name | 1 | 20140508 |
| 8ee71591-1d8f-e24e-242b-bfef131e3168 | Product name | 1 | 20140508 |
| bff5cf99-0f45-fa15-2a76-b160c3c4cc3c | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53002-9050-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-431b-f424-e053-dadaa90a57ce | Erythromycin Ophthalmic Ointment USP 0.5% (Sterile) Rx only |
| 53002-9050-1 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-431b-f424-e053-dadaa90a57ce | Erythromycin Ophthalmic Ointment USP 0.5% (Sterile) Rx only |
| 53002-9050-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-431b-f424-e053-dadaa90a57ce | Erythromycin Ophthalmic Ointment USP 0.5% (Sterile) Rx only |
| 53002-9050-1 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d0-431b-f424-e053-dadaa90a57ce | Erythromycin Ophthalmic Ointment USP 0.5% (Sterile) Rx only |
| 53002-9050-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-431b-f424-e053-dadaa90a57ce | Erythromycin Ophthalmic Ointment USP 0.5% (Sterile) Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-9050-1 | Erythromycin | 3.5 g in 1 TUBE | OINTMENT | 3.5 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-9050 | ERYTHROMYCIN OINTMENT [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_71d154c0-9a8c-446c-8826-3c6cd1249053.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310149 | erythromycin 0.5 % (5 MG/GM) Ophthalmic Ointment | PSN | 71d154c0-9a8c-446c-8826-3c6cd1249053 | 5 |
| 310149 | erythromycin 0.005 MG/MG Ophthalmic Ointment | SCD | 71d154c0-9a8c-446c-8826-3c6cd1249053 | 5 |
| 310149 | erythromycin 0.5 % Ophthalmic Ointment | SY | 71d154c0-9a8c-446c-8826-3c6cd1249053 | 5 |
| 310149 | erythromycin 5 MG per GM Ophthalmic Ointment | SY | 71d154c0-9a8c-446c-8826-3c6cd1249053 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-9050-1 | 53002905001 | 3.5 g in 1 TUBE (53002-9050-1) | 3.5 g | 2017-10-01 | 0000-00-00 | No | No | Current |