CELESTONE SOLUSPAN

Product NDC
78206-118
11-digit product format
782060118
Labeler code
78206
Product ID
78206-118_1086d646-36dd-465c-ab6d-fc4e3b51115b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Acetate and Betamethasone Sodium Phosphate
Dosage form
INJECTION, SUSPENSION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE
Labeler
Organon LLC
Application
NDA014602
Marketing category
NDA
Marketing start
2021-06-01
Substance
BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
Active strength
3; 3 mg/mL; mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N014602-001CELESTONE SOLUSPANBETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N014602-001AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N014602-001CELESTONE SOLUSPAN3MG/ML;EQ 3MG BASE/MLINJECTABLE / INJECTIONABRLD, RS, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N014602-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N014602-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N014602-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N014602-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N014602-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N014602-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N014602-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N014602-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N014602-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N014602-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N014602-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N014602-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N014602-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N014602-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N014602-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N014602-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N014602-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N014602-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N014602-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N014602-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N014602-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N014602-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N014602-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N014602-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N014602-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N014602-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N014602-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N014602-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N014602-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N014602-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N014602-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N014602-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N014602-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N014602-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N014602-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N014602-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N014602-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N014602-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N014602-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N014602-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
CELESTONE SOLUSPAN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE ACETATE3 mg/mL
BETAMETHASONE SODIUM PHOSPHATE3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TI05AO53L7Internal UNII lookup
7BK02SCL3WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
578803Internal RxNorm lookup
578806Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bf78d1be-42d7-4837-92a5-49113a79278fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-118-01CELESTONE SOLUSPAN1 in 1 BOXINJECTION, SUSPENSION110
78206-118-01CELESTONE SOLUSPAN5 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-118-01ML - Milliliter78206-118bc027590-521a-4ced-90f2-a8d63b11186112021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-118CELESTONE SOLUSPAN (BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE) INJECTION, SUSPENSION [ORGANON LLC]9Current NDC, Legacy NDC, 2 package rows20250112_bf78d1be-42d7-4837-92a5-49113a79278f.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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CELESTONE SOLUSPANBETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATESportpharm LLC95a19c2f-c329-4ce1-a0a7-174814aac3ad2026-04-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 014602
application number: NDA014602
CELESTONE SOLUSPANBETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATEOrganon LLCbf78d1be-42d7-4837-92a5-49113a79278f2026-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 014602
application number: NDA014602
ndc (product): 78206-118

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
578803betamethasone sodium phosphate / betamethasone acetate 6 MG/ML Injectable SuspensionPSNbf78d1be-42d7-4837-92a5-49113a79278f10
578806Celestone Soluspan 6 MG/ML Injectable SuspensionPSNbf78d1be-42d7-4837-92a5-49113a79278f10
578806betamethasone 3 MG/ML / betamethasone acetate 3 MG/ML Injectable Suspension [Celestone Soluspan]SBDbf78d1be-42d7-4837-92a5-49113a79278f10
578803betamethasone 3 MG/ML / betamethasone acetate 3 MG/ML Injectable SuspensionSCDbf78d1be-42d7-4837-92a5-49113a79278f10
578803betamethasone 3 MG/ML (as betamethasone sodium phosphate) / betamethasone acetate 3 MG/ML Injectable SuspensionSYbf78d1be-42d7-4837-92a5-49113a79278f10
578806Celestone 6 MG/ML Injectable SuspensionSYbf78d1be-42d7-4837-92a5-49113a79278f10
578806Celestone Soluspan (betamethasone (as betamethasone sodium phosphate) 3 MG / betamethasone acetate 3 MG) per ML Injectable SuspensionSYbf78d1be-42d7-4837-92a5-49113a79278f10
578803betamethasone sodium phosphate / betamethasone acetate 6 MG/ML Injectable SuspensionPSN95a19c2f-c329-4ce1-a0a7-174814aac3ad2
578806Celestone Soluspan 6 MG/ML Injectable SuspensionPSN95a19c2f-c329-4ce1-a0a7-174814aac3ad2
578806betamethasone 3 MG/ML / betamethasone acetate 3 MG/ML Injectable Suspension [Celestone Soluspan]SBD95a19c2f-c329-4ce1-a0a7-174814aac3ad2
578803betamethasone 3 MG/ML / betamethasone acetate 3 MG/ML Injectable SuspensionSCD95a19c2f-c329-4ce1-a0a7-174814aac3ad2
578803betamethasone 3 MG/ML (as betamethasone sodium phosphate) / betamethasone acetate 3 MG/ML Injectable SuspensionSY95a19c2f-c329-4ce1-a0a7-174814aac3ad2
578806Celestone 6 MG/ML Injectable SuspensionSY95a19c2f-c329-4ce1-a0a7-174814aac3ad2
578806Celestone Soluspan (betamethasone (as betamethasone sodium phosphate) 3 MG / betamethasone acetate 3 MG) per ML Injectable SuspensionSY95a19c2f-c329-4ce1-a0a7-174814aac3ad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
78206-118-01782060118011 VIAL, MULTI-DOSE in 1 BOX (78206-118-01) / 5 mL in 1 VIAL, MULTI-DOSE2021-06-010000-00-00NoNoCurrent