CALCITONIN SALMON

Product NDC: 49884-161
11-digit product format: 498840161
Labeler code: 49884
Product ID: 49884-161_2801477f-6c1b-443b-a543-bdbfe8cb3d45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CALCITONIN SALMON
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Endo USA, Inc.
Application: ANDA076979
Marketing category: ANDA
Marketing start: 2009-06-08
Substance: CALCITONIN SALMON
Active strength: 200 [iU]/.09mL
Pharmacologic classes: Calcitonin [CS], Calcitonin [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A076979-001	CALCITONIN-SALMON	CALCITONIN SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB		2009-06-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076979-001	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076979-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076979-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076979-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076979-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076979-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076979-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076979-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076979-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076979-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076979-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076979-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076979-001	AB	1	`79d66fd596c7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076979-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076979-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076979-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076979-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076979-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076979-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076979-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076979-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076979-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076979-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076979-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076979-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076979-001	AB	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076979-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076979-001	AB	1	`a50c72e98297…`

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]/.09mL

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
313919	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
a6eaedb3-5c96-4859-be43-a48c9c818bc7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2ae5d83d-b2bd-30a6-654a-2c8aed49ff95	Product name	3	20250130
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
5fa4b33f-5167-4398-beb0-63a0d0d1dc17	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-08-25	These highlights do not include all the information needed to use CALCITONIN SALMON NASAL SOLUTION safely and effectively. See full prescribing information for CALCITONIN SALMON NASAL SOLUTION . CALCITONIN SALMON nasal solution, for intranasal use (Synthetic Origin) Initial U.S. Approval: 1975
2022-08-25	These highlights do not include all the information needed to use CALCITONIN SALMON NASAL SOLUTION safely and effectively. See full prescribing information for CALCITONIN SALMON NASAL SOLUTION . CALCITONIN SALMON nasal solution, for intranasal use (Synthetic Origin) Initial U.S. Approval: 1975
2022-07-29	These highlights do not include all the information needed to use CALCITONIN SALMON NASAL SOLUTION safely and effectively. See full prescribing information for CALCITONIN SALMON NASAL SOLUTION . CALCITONIN SALMON nasal solution, for intranasal use (Synthetic Origin) Initial U.S. Approval: 1975
2022-07-29	These highlights do not include all the information needed to use CALCITONIN SALMON NASAL SOLUTION safely and effectively. See full prescribing information for CALCITONIN SALMON NASAL SOLUTION . CALCITONIN SALMON nasal solution, for intranasal use (Synthetic Origin) Initial U.S. Approval: 1975

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49884-161-11	CALCITONIN SALMON	3.7 mL in 1 BOTTLE, GLASS	SPRAY, METERED	3.7		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-161-11	ML - Milliliter	49884-161	90640a7c-99d4-4fe7-a67a-a9bb8a9bd6e1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CALCITONIN SALMON	ACTIVE INGREDIENT	7SFC6U2VI5	CALCITONIN SALMON SPRAY, METERED [PAR PHARMACEUTICAL INC. (MGC)]	9
CALCITONIN SALMON	ACTIVE MOIETY	7SFC6U2VI5	CALCITONIN SALMON SPRAY, METERED [PAR PHARMACEUTICAL INC. (MGC)]	9
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CALCITONIN SALMON SPRAY, METERED [PAR PHARMACEUTICAL INC. (MGC)]	9
NITROGEN	INACTIVE INGREDIENT	N762921K75	CALCITONIN SALMON SPRAY, METERED [PAR PHARMACEUTICAL INC. (MGC)]	9
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CALCITONIN SALMON SPRAY, METERED [PAR PHARMACEUTICAL INC. (MGC)]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	CALCITONIN SALMON SPRAY, METERED [PAR PHARMACEUTICAL INC. (MGC)]	9
CALCITONIN SALMON	ACTIVE INGREDIENT	7SFC6U2VI5	CALCITONIN SALMON SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]	1
CALCITONIN SALMON	ACTIVE MOIETY	7SFC6U2VI5	CALCITONIN SALMON SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	CALCITONIN SALMON SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]	1
NITROGEN	INACTIVE INGREDIENT	N762921K75	CALCITONIN SALMON SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	CALCITONIN SALMON SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CALCITONIN SALMON SPRAY, METERED [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-161	CALCITONIN SALMON SPRAY, METERED [ENDO USA, INC.]	19	Current NDC, Legacy NDC, 1 package rows	20240913_a6eaedb3-5c96-4859-be43-a48c9c818bc7.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CALCITONIN SALMON	CALCITONIN SALMON	Par Health USA, LLC	a6eaedb3-5c96-4859-be43-a48c9c818bc7	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076979 application number: ANDA076979 ndc (product): 49884-161

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7SFC6U2VI5	CALCITONIN SALMON	47931-85-1	CALCITONIN SALMON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313919	calcitonin salmon 200 UNT/ACTUAT Nasal Spray	PSN	a6eaedb3-5c96-4859-be43-a48c9c818bc7	19
313919	salmon calcitonin 200 UNT/ACTUAT Nasal Spray	SCD	a6eaedb3-5c96-4859-be43-a48c9c818bc7	19
313919	calcitonin salmon 200 UNT/ACTUAT (2200 UNT/ML) Nasal Spray	SY	a6eaedb3-5c96-4859-be43-a48c9c818bc7	19
313919	calcitonin salmon 200 UNT/ACTUAT Nasal Spray	PSN	1d20ac74-4cd8-4277-9e43-79df44c26254	1
313919	salmon calcitonin 200 UNT/ACTUAT Nasal Spray	SCD	1d20ac74-4cd8-4277-9e43-79df44c26254	1
313919	calcitonin salmon 200 UNT/ACTUAT (2200 UNT/ML) Nasal Spray	SY	1d20ac74-4cd8-4277-9e43-79df44c26254	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-161-11	49884016111	3.7 mL in 1 BOTTLE, GLASS (49884-161-11)	3.7 ml	2009-06-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CALCITONIN SALMON	Par Health USA, LLC	2026-06-29	HUMAN PRESCRIPTION DRUG LABEL	22
CALCITONIN SALMON	Bryant Ranch Prepack	2022-04-19	HUMAN PRESCRIPTION DRUG LABEL	101
Calcitonin-Salmon Nasal Spray, USP Rx Only Prescribing Information	Physicians Total Care, Inc.	2011-12-12	HUMAN PRESCRIPTION DRUG LABEL	1