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 42 .
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 2026-08-18 06:07:40 2026-07 A212675-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2024-12-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212675-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2024-12-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212675-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2024-12-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212675-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2024-12-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212675-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2024-12-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212675-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2024-12-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212675-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2024-12-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212675-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2024-12-05 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212675-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2024-12-05 a50c72e98297…
Observed Orange Book normalized TE history# 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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308866 Internal RxNorm 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
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.
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