Dicloxacillin Sodium
- Product NDC
- 55289-592
- 11-digit product format
- 552890592
- Labeler code
- 55289
- Product ID
- 55289-592_419b12d0-b5a9-5656-e063-6394a90a2d15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dicloxacillin Sodium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA062286
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Substance
- DICLOXACILLIN SODIUM
- Active strength
- 250 mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [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 |
|---|---|---|---|---|---|---|---|
| A062286-001 | DICLOXACILLIN SODIUM | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | |
| A062286-002 | DICLOXACILLIN SODIUM | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | AB | RS | 1982-06-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A062286-001 | AB |
| A062286-002 | AB |
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 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | AB | RS | 1982-06-03 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | AB | RS | 1982-06-03 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | AB | RS | 1982-06-03 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | AB | RS | 1982-06-03 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | AB | RS | 1982-06-03 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | AB | RS | 1982-06-03 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | AB | RS | 1982-06-03 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | AB | RS | 1982-06-03 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | AB | RS | 1982-06-03 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | AB | RS | 1982-06-03 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | AB | RS | 1982-06-03 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | AB | RS | 1982-06-03 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | AB | RS | 1982-06-03 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | AB | RS | 1982-06-03 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | 1982-06-03 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | RS | 1982-06-03 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | 1982-06-03 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | RS | 1982-06-03 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | 1982-06-03 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | RS | 1982-06-03 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | AB | 1982-06-03 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | 1982-06-03 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | RS | 1982-06-03 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A062286-001 | DICLOXACILLIN SODIUM | EQ 250MG BASE | CAPSULE / ORAL | 1982-06-03 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A062286-002 | DICLOXACILLIN SODIUM | EQ 500MG BASE | CAPSULE / ORAL | RS | 1982-06-03 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A062286-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A062286-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062286-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062286-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A062286-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A062286-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062286-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062286-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062286-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062286-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062286-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062286-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062286-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062286-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062286-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062286-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062286-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062286-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A062286-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A062286-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062286-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062286-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062286-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062286-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062286-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062286-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A062286-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A062286-002 | AB | 1 | 8072bd15b7f6… |
| 2019-12-13 00:20 UTC | 2019-12 | A062286-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A062286-002 | AB | 1 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | A062286-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A062286-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A062286-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A062286-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A062286-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A062286-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A062286-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A062286-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A062286-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A062286-002 | AB | 1 | ea99ee380514… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dicloxacillin Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DICLOXACILLIN SODIUM | 250 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4HZT2V9KX0 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 197595 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9e2bbe03-44cb-45d1-acdb-b61d9016055e | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ce7f6212-eff4-e8f0-b733-f4aa5877dfa0 | Product name | 2 | 20231211 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55289-592-10 | Dicloxacillin Sodium | 10 in 1 BOTTLE, PLASTIC | CAPSULE | 10 | 16 | |
| 55289-592-20 | Dicloxacillin Sodium | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | 16 | |
| 55289-592-28 | Dicloxacillin Sodium | 28 in 1 BOTTLE, PLASTIC | CAPSULE | 28 | 16 | |
| 55289-592-40 | Dicloxacillin Sodium | 40 in 1 BOTTLE, PLASTIC | CAPSULE | 40 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55289-592-10 | EA - Each | 55289-592 | 18d9dc9a-8e5e-48e3-8c75-95604d451afe | 1 | 2012-07-24 |
| 55289-592-20 | EA - Each | 55289-592 | 4a26060e-6390-406f-839b-7ae7e8d1c758 | 1 | 2012-07-24 |
| 55289-592-28 | EA - Each | 55289-592 | fad28969-e8c3-412c-a4c0-e2217e467af6 | 1 | 2012-07-24 |
| 55289-592-40 | EA - Each | 55289-592 | a31dffd7-9dbf-4494-b485-ed40b11a49a1 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| DICLOXACILLIN SODIUM | DICLOXACILLIN SODIUM | Chartwell RX, LLC | 270c0839-c30c-475d-a505-e70855652c9e | 2026-07-23 | Warnings, Adverse reactions | 062286 ANDA062286 |
| Dicloxacillin Sodium | DICLOXACILLIN SODIUM | PD-Rx Pharmaceuticals, Inc. | c17cd62d-ff5d-47ba-8673-3346c7f2365f | 2026-05-21 | Warnings, Adverse reactions | 062286 ANDA062286 |
| Dicloxacillin Sodium | DICLOXACILLIN SODIUM | PD-Rx Pharmaceuticals, Inc. | 9e2bbe03-44cb-45d1-acdb-b61d9016055e | 2025-10-20 | Warnings, Adverse reactions | 062286 ANDA062286 55289-592 |
| Dicloxacillin Sodium | DICLOXACILLIN SODIUM | PD-Rx Pharmaceuticals, Inc. | 24e821aa-85b8-4f5a-aa13-83ff132952ca | 2025-10-15 | Warnings, Adverse reactions | 062286 ANDA062286 |
| Dicloxacillin Sodium | DICLOXACILLIN SODIUM | Bryant Ranch Prepack | 3e4842ec-773b-4aeb-b37d-1c4e3cf53424 | 2024-01-18 | Warnings, Adverse reactions | 062286 ANDA062286 |
| Dicloxacillin Sodium | DICLOXACILLIN SODIUM | Teva Pharmaceuticals USA, Inc. | 8478f242-c715-4984-ac1d-dc79dc28665e | 2022-06-22 | Warnings, Adverse reactions | 062286 ANDA062286 |
| Dicloxacillin Sodium | DICLOXACILLIN SODIUM | Asclemed USA, Inc. | a4174fda-68f7-4834-be58-dd6b167cf9f0 | 2020-11-14 | Warnings, Adverse reactions | 062286 ANDA062286 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197595 | dicloxacillin sodium 250 MG Oral Capsule | PSN | 9e2bbe03-44cb-45d1-acdb-b61d9016055e | 16 |
| 197595 | dicloxacillin 250 MG Oral Capsule | SCD | 9e2bbe03-44cb-45d1-acdb-b61d9016055e | 16 |
| 197595 | dicloxacillin (as dicloxacillin sodium) 250 MG Oral Capsule | SY | 9e2bbe03-44cb-45d1-acdb-b61d9016055e | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55289-592-10 | 55289059210 | 10 CAPSULE in 1 BOTTLE, PLASTIC (55289-592-10) | 10 capsule | 2011-01-20 | 0000-00-00 | No | No | Current |
| 55289-592-20 | 55289059220 | 20 CAPSULE in 1 BOTTLE, PLASTIC (55289-592-20) | 20 capsule | 2011-01-20 | 0000-00-00 | No | No | Current |
| 55289-592-28 | 55289059228 | 28 CAPSULE in 1 BOTTLE, PLASTIC (55289-592-28) | 28 capsule | 2011-01-20 | 0000-00-00 | No | No | Current |
| 55289-592-40 | 55289059240 | 40 CAPSULE in 1 BOTTLE, PLASTIC (55289-592-40) | 40 capsule | 2011-01-20 | 0000-00-00 | No | No | Current |