Erythromycin
- Product NDC
- 60760-670
- 11-digit product format
- 607600670
- Labeler code
- 60760
- Product ID
- 60760-670_2cc7203b-1bf0-ccda-e063-6394a90ac207
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Erythromycin
- Dosage form
- OINTMENT
- Route
- OPHTHALMIC
- Labeler
- ST. MARY'S MEDICAL PARK PHARMACY
- Application
- ANDA064030
- Marketing category
- ANDA
- Marketing start
- 2023-10-18
- Substance
- ERYTHROMYCIN
- Active strength
- 5 mg/g
- Pharmacologic classes
- Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A064030-001 | ERYTHROMYCIN | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A064030-001 | AT |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A064030-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | 1996-07-18 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A064030-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064030-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A064030-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064030-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064030-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064030-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064030-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064030-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064030-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A064030-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064030-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064030-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064030-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A064030-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064030-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A064030-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A064030-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A064030-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A064030-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A064030-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064030-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A064030-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A064030-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A064030-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A064030-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A064030-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A064030-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A064030-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A064030-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A064030-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064030-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064030-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064030-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064030-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A064030-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A064030-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064030-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A064030-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A064030-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A064030-001 | AT | 1 | cb3db0bc1861… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Erythromycin | ERYTHROMYCIN | NuCare Pharmaceuticals,Inc. | 50c8d6b3-4660-e829-e063-6294a90a919b | 2026-05-01 | Adverse reactions | 064030 ANDA064030 |
| Erythromycin | ERYTHROMYCIN | Sentiss Pharmaceuticals LLC | 4da0e351-383f-55da-e063-6394a90a8eba | 2026-03-31 | Adverse reactions | 064030 ANDA064030 |
| Erythromycin | ERYTHROMYCIN | Redpharm Drug | 301ee5ad-3b6c-1152-e063-6294a90a54e7 | 2025-12-23 | Adverse reactions | 064030 ANDA064030 |
| Erythromycin | ERYTHROMYCIN | ST. MARY'S MEDICAL PARK PHARMACY | 2cc726c2-3746-6dbf-e063-6294a90a789f | 2025-01-28 | Adverse reactions | 064030 ANDA064030 60760-670 |
| Erythromycin | ERYTHROMYCIN | ARMAS PHARMACEUTICALS INC. | 07fdeac5-f690-d74b-e063-6394a90a5c5b | 2023-10-23 | Adverse reactions | 064030 ANDA064030 |
| Erythromycin | ERYTHROMYCIN | Proficient Rx LP | 62896bec-669e-4f20-a1e4-4f99afd35d32 | 2022-04-01 | Adverse reactions | 064030 ANDA064030 |
| Erythromycin | ERYTHROMYCIN | Asclemed USA, Inc. | bccdb8f3-b5f5-4f07-8ddb-8811d5c1b73c | 2022-03-07 | Adverse reactions | 064030 ANDA064030 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Erythromycin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ERYTHROMYCIN | 5 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 63937KV33D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 310149 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2cc726c2-3746-6dbf-e063-6294a90a789f | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 60760-670-35 | Erythromycin | 3.5 g in 1 TUBE | OINTMENT | 3.5 | 1 | |
| 60760-670-35 | Erythromycin | 1 in 1 CARTON | OINTMENT | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60760-670-35 | GM - Gram | 60760-670 | f155603c-6a43-49b0-95c7-3e96a3484a92 | 1 | 2025-03-04 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310149 | erythromycin 0.5 % (5 MG/GM) Ophthalmic Ointment | PSN | 2cc726c2-3746-6dbf-e063-6294a90a789f | 1 |
| 310149 | erythromycin 0.005 MG/MG Ophthalmic Ointment | SCD | 2cc726c2-3746-6dbf-e063-6294a90a789f | 1 |
| 310149 | erythromycin 0.5 % Ophthalmic Ointment | SY | 2cc726c2-3746-6dbf-e063-6294a90a789f | 1 |
| 310149 | erythromycin 5 MG per GM Ophthalmic Ointment | SY | 2cc726c2-3746-6dbf-e063-6294a90a789f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60760-670-35 | 60760067035 | 1 TUBE in 1 CARTON (60760-670-35) / 3.5 g in 1 TUBE | 1 tube | 2025-01-22 | No | No | Current |