Photofrin

Product NDC
76128-155
11-digit product format
761280155
Labeler code
76128
Product ID
76128-155_a11b84ff-6eb6-4bba-9c7c-6d41bdfe2d57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Porfimer Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Pinnacle Biologics, Inc.
Application
NDA020451
Marketing category
NDA
Marketing start
1995-12-27
Substance
PORFIMER SODIUM
Active strength
75 mg/31.8mL
Pharmacologic classes
Photoabsorption [MoA], Photoactivated Radical Generator [EPC], Photosensitizing Activity [PE]
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 42.

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
N020451-001PHOTOFRINPORFIMER SODIUM75MG/VIALINJECTABLE / INJECTION1995-12-27

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-273f01610625f2…
2019-09-15 20:21 UTC2019-09N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020451-001PHOTOFRIN75MG/VIALINJECTABLE / INJECTION1995-12-27e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PORFIMER SODIUM75 mg/31.8mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Y3834SIK5FInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
242166Internal RxNorm lookup
687066Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5c4841b4-fbc0-4163-8ee1-cb28629cbfbfAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76128-155-75Photofrin31.8 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION31.815
76128-155-75Photofrin1 in 1 BOX, UNIT-DOSEINJECTION, POWDER, FOR SOLUTION115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76128-155-75EA - Each76128-155675cc726-62a5-4233-938b-54335249e58212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
porfimer sodiumACTIVE INGREDIENTY3834SIK5FPHOTOFRIN (PORFIMER SODIUM) INJECTION, POWDER, FOR SOLUTION [PINNACLE BIOLOGICS, INC.]4
porfimerACTIVE MOIETYM15H03K69BPHOTOFRIN (PORFIMER SODIUM) INJECTION, POWDER, FOR SOLUTION [PINNACLE BIOLOGICS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76128-155PHOTOFRIN (PORFIMER SODIUM) INJECTION, POWDER, FOR SOLUTION [PINNACLE BIOLOGICS, INC.]14Current NDC, Legacy NDC, 2 package rows20250221_5c4841b4-fbc0-4163-8ee1-cb28629cbfbf.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhotofrinPORFIMER SODIUMPinnacle Biologics, Inc.5c4841b4-fbc0-4163-8ee1-cb28629cbfbf2026-04-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 020451
application number: NDA020451
ndc (product): 76128-155

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
687066PHOTOFRIN 75 MG InjectionPSN5c4841b4-fbc0-4163-8ee1-cb28629cbfbf15
242166porfimer sodium 75 MG InjectionPSN5c4841b4-fbc0-4163-8ee1-cb28629cbfbf15
687066porfimer sodium 75 MG Injection [Photofrin]SBD5c4841b4-fbc0-4163-8ee1-cb28629cbfbf15
242166porfimer sodium 75 MG InjectionSCD5c4841b4-fbc0-4163-8ee1-cb28629cbfbf15
687066Photofrin 75 MG (as porfimer sodium) InjectionSY5c4841b4-fbc0-4163-8ee1-cb28629cbfbf15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76128-155-75761280155751 VIAL in 1 BOX, UNIT-DOSE (76128-155-75) / 31.8 mL in 1 VIAL1 vial1995-12-270000-00-00NoNoCurrent