Dexamethasone Sodium Phosphate
- Product NDC
- 63323-506
- 11-digit product format
- 633230506
- Labeler code
- 63323
- Product ID
- 63323-506_9320abbb-bfd8-4df2-9269-3a52736c190f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DEXAMETHASONE SODIUM PHOSPHATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA040491
- Marketing category
- ANDA
- Marketing start
- 2003-05-29
- Substance
- DEXAMETHASONE SODIUM PHOSPHATE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | DEXAMETHASONE SODIUM PHOSPHATE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040491-001 | AP |
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 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040491-001 | DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE | EQ 10MG PHOSPHATE/ML | INJECTABLE / INJECTION | AP | RS | 2003-04-11 | 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 | A040491-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040491-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040491-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040491-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040491-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040491-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040491-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040491-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040491-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040491-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040491-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040491-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040491-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040491-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040491-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040491-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040491-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040491-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040491-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040491-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040491-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040491-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040491-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040491-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040491-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040491-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040491-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040491-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040491-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040491-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040491-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040491-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040491-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040491-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040491-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040491-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040491-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040491-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A040491-001 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040491-001 | AP | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dexamethasone Sodium Phosphate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXAMETHASONE SODIUM PHOSPHATE | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| AI9376Y64P | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cca2c160-9188-48e8-9505-49a52388dcb7 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-506-00 | Dexamethasone Sodium Phosphate | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | 11 | |
| 63323-506-01 | Dexamethasone Sodium Phosphate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 11 | |
| 63323-506-03 | Dexamethasone Sodium Phosphate | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | 11 | |
| 63323-506-13 | Dexamethasone Sodium Phosphate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 11 | |
| 63323-506-16 | Dexamethasone Sodium Phosphate | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 6 | |
| 63323-506-41 | Dexamethasone Sodium Phosphate | 1 mL in 1 VIAL | INJECTION, SOLUTION | 1 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-506-00 | ML - Milliliter | 63323-506 | 71ad9250-729d-4314-a173-726b59b5b064 | 1 | 2025-02-10 |
| 63323-506-01 | ML - Milliliter | 63323-506 | 2a123e79-c97d-40f5-9033-42c7dcedf50e | 1 | 2012-07-24 |
| 63323-506-16 | ML - Milliliter | 63323-506 | 13287c28-32ad-4a0f-b3b5-51c2b12dc378 | 1 | 2015-12-02 |
| 63323-506-41 | ML - Milliliter | 63323-506 | c8f3093c-7422-4229-ab1f-daa795c28d9e | 1 | 2022-03-09 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63323-506 | DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, MARICAINE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] | 10 | Current NDC, Legacy NDC | 20241008_d3fd1d51-7749-4e1e-a8b5-8a151392f66d.zip |
| 63323-506 | DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ] | 9 | Current NDC, Legacy NDC, 4 package rows | 20240725_cca2c160-9188-48e8-9505-49a52388dcb7.zip |
| 63323-506 | DEXLIDO KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] | 9 | Current NDC, Legacy NDC | 20241008_65428186-5fbb-4e1a-ae60-8824f3d62179.zip |
| 63323-506 | MARDEX 25 KIT (DEXAMETHASONE SODIUM PHOSPHATE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] | 9 | Current NDC, Legacy NDC | 20241008_94472ddb-ae1d-4a11-a673-81254d562e6b.zip |
| 63323-506 | DOUBLEDEX KIT (DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] | 8 | Current NDC, Legacy NDC | 20241008_b7d58d9b-e1fa-4a7f-afca-beb06d028057.zip |
| 63323-506 | DEXAMETHASONE SODIUM PHOSPHATE (DEXAMETHASONE SODIUM PHOSPHATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ] | 5 | Current NDC, Legacy NDC, 2 package rows | 20210526_7cbd9005-7df2-47ee-adb3-7244c1c69bc3.zip |
| 63323-506 | ROPIDEX (DEXAMETHASONE SODIUM PHOSPHATE, ROPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [ASCLEMED USA, INC.] | 4 | Current NDC, Legacy NDC | 20241008_2577c1ba-8aff-4098-ba11-a375e9ce3caa.zip |
| 63323-506 | DOUBLEDEX KIT (DEXAMETHASONE SODIUM PHOSPHATE, POVIDINE IODINE) KIT [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 2 | Current NDC, Legacy NDC | 20250102_fb85dd2c-6c90-6249-e053-6294a90a09fa.zip |
| 63323-506 | DEXLIDO-M KIT (DEXAMETHASONE SODIUM PHOSPHATE, LIDOCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE, POVIDINE IODINE) KIT [PROFICIENT RX LP] | 1 | Current NDC, Legacy NDC | 20150407_fd895819-b7d4-43bd-b804-f7b0722a00e9.zip |
| 63323-506 | MAS CARE-PAK DEXAMETHASONE (DEXAMETHASONE SODIUM PHOSPHATE) KIT [MAS MANAGEMENT GROUP INC.] | 1 | Current NDC, Legacy NDC | 20171207_5d6b905f-ed31-1ab7-e053-2a91aa0a816b.zip |
| 63323-506 | TOPIDEX (DEXAMETHASONE SURGICAL COMBO KIT) KIT [TOPICARE MANAGEMENT, LLC] | 1 | Current NDC, Legacy NDC | 20180418_69333734-6370-4310-e053-2a91aa0a611c.zip |
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 |
|---|---|---|---|---|---|---|
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | cca2c160-9188-48e8-9505-49a52388dcb7 | 2026-06-30 | Warnings, Adverse reactions | 040491 ANDA040491 63323-506 |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Fresenius Kabi USA, LLC | 7cbd9005-7df2-47ee-adb3-7244c1c69bc3 | 2026-06-30 | Warnings, Adverse reactions | 040491 ANDA040491 63323-506 |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Sportpharm LLC | 6c7ff5f7-5688-4fc4-9194-9e6b8e6fab59 | 2026-04-24 | Warnings, Adverse reactions | 040491 ANDA040491 |
| Dexamethasone Sodium Phosphate | DEXAMETHASONE SODIUM PHOSPHATE | Sportpharm LLC | 56bdd2f3-ae94-4fd9-9d05-5b53263a09c1 | 2026-03-20 | Warnings, Adverse reactions | 040491 ANDA040491 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1725078 | BUPivacaine HCl 0.25 % in 10 ML Injection | PSN | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 1812079 | dexAMETHasone sodium phosphate 10 MG in 1 ML Injection | PSN | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 1812079 | dexAMETHasone sodium phosphate 10 MG in 1 ML Injection | PSN | cca2c160-9188-48e8-9505-49a52388dcb7 | 11 |
| 309696 | dexAMETHasone sodium phosphate 10 MG/ML (dexAMETHasone phosphate equivalent) Injectable Solution | PSN | cca2c160-9188-48e8-9505-49a52388dcb7 | 11 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 1737568 | lidocaine HCl 1 % in 2 ML Injection | PSN | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 797730 | povidone-iodine 10 % Medicated Pad | PSN | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 1812079 | 1 ML dexamethasone phosphate 10 MG/ML Injection | SCD | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 1812079 | 1 ML dexamethasone phosphate 10 MG/ML Injection | SCD | cca2c160-9188-48e8-9505-49a52388dcb7 | 11 |
| 1725078 | 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 1737568 | 2 ML lidocaine hydrochloride 10 MG/ML Injection | SCD | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 309696 | dexamethasone phosphate 10 MG/ML Injectable Solution | SCD | cca2c160-9188-48e8-9505-49a52388dcb7 | 11 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 797730 | povidone-iodine 100 MG/ML Medicated Pad | SCD | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 1725078 | bupivacaine HCl 0.25 % in 10 ML Injection | SY | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 1812079 | dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML Injection | SY | cca2c160-9188-48e8-9505-49a52388dcb7 | 11 |
| 1812079 | dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML Injection | SY | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 309696 | dexamethasone phosphate 10 MG/ML (as dexamethasone sodium phosphate 11 MG/ML) Injectable Solution | SY | cca2c160-9188-48e8-9505-49a52388dcb7 | 11 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 1737568 | lidocaine HCl 1 % per 2 ML Injection | SY | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 1737568 | lidocaine HCl 20 MG per 2 ML Injection | SY | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 797730 | povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad | SY | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 797730 | povidone-iodine 10 % Medicated Pad | SY | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 797730 | povidone-iodine 10 % Medicated Swabstick | SY | d3fd1d51-7749-4e1e-a8b5-8a151392f66d | 11 |
| 1725078 | BUPivacaine HCl 0.25 % in 10 ML Injection | PSN | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 1725082 | BUPivacaine HCl 0.25 % in 30 ML Injection | PSN | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 1812079 | dexAMETHasone sodium phosphate 10 MG in 1 ML Injection | PSN | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 1812079 | dexAMETHasone sodium phosphate 10 MG in 1 ML Injection | PSN | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 1737568 | lidocaine HCl 1 % in 2 ML Injection | PSN | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 797730 | povidone-iodine 10 % Medicated Pad | PSN | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 797730 | povidone-iodine 10 % Medicated Pad | PSN | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 1812079 | 1 ML dexamethasone phosphate 10 MG/ML Injection | SCD | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 1812079 | 1 ML dexamethasone phosphate 10 MG/ML Injection | SCD | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 1725078 | 10 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 1737568 | 2 ML lidocaine hydrochloride 10 MG/ML Injection | SCD | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 1725082 | 30 ML bupivacaine hydrochloride 2.5 MG/ML Injection | SCD | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 797730 | povidone-iodine 100 MG/ML Medicated Pad | SCD | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 797730 | povidone-iodine 100 MG/ML Medicated Pad | SCD | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 1725078 | bupivacaine HCl 0.25 % in 10 ML Injection | SY | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 1725082 | bupivacaine HCl 0.25 % per 30 ML Injection | SY | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 1812079 | dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML Injection | SY | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 1812079 | dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML Injection | SY | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 1737568 | lidocaine HCl 1 % per 2 ML Injection | SY | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 1737568 | lidocaine HCl 20 MG per 2 ML Injection | SY | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 797730 | povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad | SY | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 797730 | povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad | SY | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 797730 | povidone-iodine 10 % Medicated Pad | SY | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 797730 | povidone-iodine 10 % Medicated Pad | SY | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 797730 | povidone-iodine 10 % Medicated Swabstick | SY | 65428186-5fbb-4e1a-ae60-8824f3d62179 | 10 |
| 797730 | povidone-iodine 10 % Medicated Swabstick | SY | 94472ddb-ae1d-4a11-a673-81254d562e6b | 10 |
| 1812079 | dexAMETHasone sodium phosphate 10 MG in 1 ML Injection | PSN | b7d58d9b-e1fa-4a7f-afca-beb06d028057 | 9 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | PSN | b7d58d9b-e1fa-4a7f-afca-beb06d028057 | 9 |
| 797730 | povidone-iodine 10 % Medicated Pad | PSN | b7d58d9b-e1fa-4a7f-afca-beb06d028057 | 9 |
| 1812079 | 1 ML dexamethasone phosphate 10 MG/ML Injection | SCD | b7d58d9b-e1fa-4a7f-afca-beb06d028057 | 9 |
| 797544 | isopropyl alcohol 0.7 ML/ML Medicated Pad | SCD | b7d58d9b-e1fa-4a7f-afca-beb06d028057 | 9 |
| 797730 | povidone-iodine 100 MG/ML Medicated Pad | SCD | b7d58d9b-e1fa-4a7f-afca-beb06d028057 | 9 |
| 1812079 | dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML Injection | SY | b7d58d9b-e1fa-4a7f-afca-beb06d028057 | 9 |
| 797544 | isopropyl alcohol 70 % Medicated Pad | SY | b7d58d9b-e1fa-4a7f-afca-beb06d028057 | 9 |
| 797544 | isopropyl alcohol 70 % Topical Cloth | SY | b7d58d9b-e1fa-4a7f-afca-beb06d028057 | 9 |
| 797544 | isopropyl alcohol 70 % Topical Swab | SY | b7d58d9b-e1fa-4a7f-afca-beb06d028057 | 9 |
| 797730 | povidone-iodine 10 % (titratable iodine 1 % ) Medicated Pad | SY | b7d58d9b-e1fa-4a7f-afca-beb06d028057 | 9 |
| 797730 | povidone-iodine 10 % Medicated Pad | SY | b7d58d9b-e1fa-4a7f-afca-beb06d028057 | 9 |
| 797730 | povidone-iodine 10 % Medicated Swabstick | SY | b7d58d9b-e1fa-4a7f-afca-beb06d028057 | 9 |
| 1812079 | dexAMETHasone sodium phosphate 10 MG in 1 ML Injection | PSN | 7cbd9005-7df2-47ee-adb3-7244c1c69bc3 | 6 |
| 1812079 | 1 ML dexamethasone phosphate 10 MG/ML Injection | SCD | 7cbd9005-7df2-47ee-adb3-7244c1c69bc3 | 6 |
| 1812079 | dexamethasone phosphate 10 MG (as dexamethasone sodium phosphate 11 MG) per 1 ML Injection | SY | 7cbd9005-7df2-47ee-adb3-7244c1c69bc3 | 6 |
| 1812079 | dexAMETHasone sodium phosphate 10 MG in 1 ML Injection | PSN | 2577c1ba-8aff-4098-ba11-a375e9ce3caa | 4 |
| 797730 | povidone-iodine 10 % Medicated Pad | PSN | 2577c1ba-8aff-4098-ba11-a375e9ce3caa | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63323-506-00 | 63323050600 | 1 mL in 1 VIAL | 1 ml | Historical | ||||
| 63323-506-01 | 63323050601 | 25 VIAL in 1 TRAY (63323-506-01) / 1 mL in 1 VIAL (63323-506-00) | 25 vial | 2003-05-29 | 0000-00-00 | No | No | Current |
| 63323-506-03 | 63323050603 | 1 mL in 1 VIAL | 1 ml | Historical | ||||
| 63323-506-13 | 63323050613 | 25 VIAL in 1 TRAY (63323-506-13) / 1 mL in 1 VIAL (63323-506-03) | 25 vial | 2025-01-06 | No | No | Current | |
| 63323-506-16 | 63323050616 | 25 VIAL in 1 TRAY (63323-506-16) / 1 mL in 1 VIAL (63323-506-41) | 25 vial | 2003-05-29 | 0000-00-00 | No | No | Current |
| 63323-506-41 | 63323050641 | 1 mL in 1 VIAL | 1 ml | Historical |