Home NDC 63323-865 Calcitonin Salmon
Product NDC 63323-865
11-digit product format 633230865
Labeler code 63323
Product ID 63323-865_c4bad3c0-7401-48f4-9a40-ecae623446cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcitonin Salmon
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; SUBCUTANEOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA212675
Marketing category ANDA
Marketing start 2024-12-05
Substance CALCITONIN SALMON
Active strength 200 [iU]/mL
Pharmacologic classes Calcitonin [CS], Calcitonin [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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212675-001 CALCITONIN-SALMON CALCITONIN SALMON 200 IU/ML INJECTABLE / INJECTION AP 2024-12-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212675-001 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 table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A212675-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2024-12-05 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A212675-001 AP 1 a50c72e98297…
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Calcitonin Salmon
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCITONIN SALMON 200 [iU]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7SFC6U2VI5 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-865-02 Calcitonin Salmon 2 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 2 2 63323-865-02 Calcitonin Salmon 1 in 1 CARTON INJECTION, SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-865 CALCITONIN SALMON INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 Current NDC, 2 package rows 20241220_2b8c6917-c217-45bf-a0ac-a2fa0f7d497a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 63323-865-02 63323086502 1 VIAL, MULTI-DOSE in 1 CARTON (63323-865-02) / 2 mL in 1 VIAL, MULTI-DOSE 2024-12-05 No No Current