PARSABIV

Product NDC: 55513-742
Requested package NDC: 55513-742-10
11-digit product format: 555130742
Labeler code: 55513
Product ID: 55513-742_52286976-a97a-4b77-b678-f40ab5aa7133
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: etelcalcetide
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Amgen, Inc
Application: NDA208325
Marketing category: NDA
Marketing start: 2017-04-03
Substance: ETELCALCETIDE HYDROCHLORIDE
Active strength: 10 mg/2mL
Pharmacologic classes: Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]
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 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N208325-001	PARSABIV	ETELCALCETIDE	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07
N208325-002	PARSABIV	ETELCALCETIDE	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07
N208325-003	PARSABIV	ETELCALCETIDE	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208325-001	8377880	2030-07-29		Drug substance, Drug product	2017-06-01
N208325-001	9278995	2030-07-29		Drug substance	2017-06-01
N208325-001	9701712	2030-07-29	U-2014	Drug substance, Drug product	2017-07-14
N208325-001	8999932	2031-02-07	U-2014	Drug substance, Drug product	2017-06-01
N208325-001	10344765	2034-06-27		Drug product	2019-07-19
N208325-001	11162500	2034-06-27		Drug product	2021-11-12
N208325-001	11959486	2034-06-27	U-2014	Drug product	2024-05-10
N208325-001	9820938	2034-06-27		Drug product	2017-11-29
N208325-002	8377880	2030-07-29		Drug substance, Drug product	2017-06-01
N208325-002	9278995	2030-07-29		Drug substance	2017-06-01
N208325-002	9701712	2030-07-29	U-2014	Drug substance, Drug product	2017-07-14
N208325-002	8999932	2031-02-07	U-2014	Drug substance, Drug product	2017-06-01
N208325-002	10344765	2034-06-27		Drug product	2019-07-19
N208325-002	11162500	2034-06-27		Drug product	2021-11-12
N208325-002	11959486	2034-06-27	U-2014	Drug product	2024-05-10
N208325-002	9820938	2034-06-27		Drug product	2017-11-29
N208325-003	8377880	2030-07-29		Drug substance, Drug product	2017-06-01
N208325-003	9278995	2030-07-29		Drug substance	2017-06-01
N208325-003	9701712	2030-07-29	U-2014	Drug substance, Drug product	2017-07-14
N208325-003	8999932	2031-02-07	U-2014	Drug substance, Drug product	2017-06-01
N208325-003	10344765	2034-06-27		Drug product	2019-07-19
N208325-003	11162500	2034-06-27		Drug product	2021-11-12
N208325-003	11959486	2034-06-27	U-2014	Drug product	2024-05-10
N208325-003	9820938	2034-06-27		Drug product	2017-11-29

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208325-002	PARSABIV	5MG/ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208325-003	PARSABIV	10MG/2ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208325-001	PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML)	SOLUTION / INTRAVENOUS	RLD, RS	2017-02-07	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 24 · 924 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N208325-001	8377880	2030-07-29		Drug substance, Drug product	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-001	9278995	2030-07-29		Drug substance	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-001	9701712	2030-07-29	U-2014	Drug substance, Drug product	2017-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-001	8999932	2031-02-07	U-2014	Drug substance, Drug product	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-001	10344765	2034-06-27		Drug product	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-001	11162500	2034-06-27		Drug product	2021-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-001	11959486	2034-06-27	U-2014	Drug product	2024-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-001	9820938	2034-06-27		Drug product	2017-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	8377880	2030-07-29		Drug substance, Drug product	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	9278995	2030-07-29		Drug substance	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	9701712	2030-07-29	U-2014	Drug substance, Drug product	2017-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	8999932	2031-02-07	U-2014	Drug substance, Drug product	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	10344765	2034-06-27		Drug product	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	11162500	2034-06-27		Drug product	2021-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	11959486	2034-06-27	U-2014	Drug product	2024-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-002	9820938	2034-06-27		Drug product	2017-11-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	8377880	2030-07-29		Drug substance, Drug product	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	9278995	2030-07-29		Drug substance	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	9701712	2030-07-29	U-2014	Drug substance, Drug product	2017-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	8999932	2031-02-07	U-2014	Drug substance, Drug product	2017-06-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	10344765	2034-06-27		Drug product	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	11162500	2034-06-27		Drug product	2021-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	11959486	2034-06-27	U-2014	Drug product	2024-05-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208325-003	9820938	2034-06-27		Drug product	2017-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208325-001	8377880	2030-07-29		Drug substance, Drug product	2017-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-001	9278995	2030-07-29		Drug substance	2017-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-001	9701712	2030-07-29	U-2014	Drug substance, Drug product	2017-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-001	8999932	2031-02-07	U-2014	Drug substance, Drug product	2017-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-001	10344765	2034-06-27		Drug product	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-001	11162500	2034-06-27		Drug product	2021-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-001	11959486	2034-06-27	U-2014	Drug product	2024-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-001	9820938	2034-06-27		Drug product	2017-11-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	8377880	2030-07-29		Drug substance, Drug product	2017-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	9278995	2030-07-29		Drug substance	2017-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	9701712	2030-07-29	U-2014	Drug substance, Drug product	2017-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	8999932	2031-02-07	U-2014	Drug substance, Drug product	2017-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	10344765	2034-06-27		Drug product	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	11162500	2034-06-27		Drug product	2021-11-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	11959486	2034-06-27	U-2014	Drug product	2024-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208325-002	9820938	2034-06-27		Drug product	2017-11-29	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208325-001	NCE	2022-02-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208325-002	NCE	2022-02-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208325-003	NCE	2022-02-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208325-001	NCE	2022-02-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208325-002	NCE	2022-02-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208325-003	NCE	2022-02-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208325-001	NCE	2022-02-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208325-002	NCE	2022-02-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208325-003	NCE	2022-02-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208325-001	NCE	2022-02-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208325-002	NCE	2022-02-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208325-003	NCE	2022-02-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208325-001	NCE	2022-02-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208325-002	NCE	2022-02-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208325-003	NCE	2022-02-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208325-001	NCE	2022-02-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208325-002	NCE	2022-02-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208325-003	NCE	2022-02-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208325-001	NCE	2022-02-07	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208325-002	NCE	2022-02-07	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208325-003	NCE	2022-02-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208325-001	NCE	2022-02-07	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208325-002	NCE	2022-02-07	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208325-003	NCE	2022-02-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208325-001	NCE	2022-02-07	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208325-002	NCE	2022-02-07	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208325-003	NCE	2022-02-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208325-001	NCE	2022-02-07	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208325-002	NCE	2022-02-07	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208325-003	NCE	2022-02-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208325-001	NCE	2022-02-07	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208325-002	NCE	2022-02-07	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208325-003	NCE	2022-02-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208325-001	NCE	2022-02-07	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208325-002	NCE	2022-02-07	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208325-003	NCE	2022-02-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208325-001	NCE	2022-02-07	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208325-002	NCE	2022-02-07	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208325-003	NCE	2022-02-07	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N208325-001	NCE	2022-02-07	`3bdfa0b2c4d7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ETELCALCETIDE HYDROCHLORIDE	10 mg/2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
72PT5993DU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1876127	Internal RxNorm lookup
1876132	Internal RxNorm lookup
1876135	Internal RxNorm lookup
1876136	Internal RxNorm lookup
1876137	Internal RxNorm lookup
1876138	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
cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4f16c46d-505e-4d40-8b28-136c0bf8147d	Product name	1	20170501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55513-742-01	PARSABIV	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2	15
55513-742-10	PARSABIV	10 in 1 CARTON	INJECTION, SOLUTION	10	15
55513-742-20	PARSABIV	10 in 1 CARTON	INJECTION, SOLUTION	10	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55513-742-01	ML - Milliliter	55513-742	0512b3b0-0241-49ec-a048-45d841d6ead1	1	2017-11-06
55513-742-10	ML - Milliliter	55513-742	5796bffb-4eff-4fe3-a415-b430300b5eba	1	2017-11-06
55513-742-20	ML - Milliliter	55513-742	7ded736a-e5a9-4680-a8ae-d146e664a3b3	1	2026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55513-742	PARSABIV (ETELCALCETIDE) INJECTION, SOLUTION [AMGEN INC]	13	Current NDC, Legacy NDC, 3 package rows	20220626_cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c.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
PARSABIV	ETELCALCETIDE	Amgen, Inc	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	2026-03-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208325 application number: NDA208325 ndc (package): 55513-742-10 ndc (product): 55513-742 ndc11 (package): 55513074210

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
72PT5993DU	ETELCALCETIDE HYDROCHLORIDE	1334237-71-6	ETELCALCETIDE HYDROCHLORIDE
60ME133FJB	ETELCALCETIDE	1262780-97-1	etelcalcetide

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1876127	etelcalcetide 10 MG in 2 ML Injection	PSN	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876137	etelcalcetide 2.5 MG in 0.5 ML Injection	PSN	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876135	etelcalcetide 5 MG in 1 ML Injection	PSN	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876132	Parsabiv 10 MG in 2 ML Injection	PSN	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876138	Parsabiv 2.5 MG in 0.5 ML Injection	PSN	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876136	Parsabiv 5 MG in 1 ML Injection	PSN	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876138	0.5 ML etelcalcetide 5 MG/ML Injection [Parsabiv]	SBD	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876136	1 ML etelcalcetide 5 MG/ML Injection [Parsabiv]	SBD	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876132	2 ML etelcalcetide 5 MG/ML Injection [Parsabiv]	SBD	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876137	0.5 ML etelcalcetide 5 MG/ML Injection	SCD	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876135	1 ML etelcalcetide 5 MG/ML Injection	SCD	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876127	2 ML etelcalcetide 5 MG/ML Injection	SCD	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876127	etelcalcetide 10 MG per 2 ML Injection	SY	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876137	etelcalcetide 2.5 MG per 0.5 ML Injection	SY	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876135	etelcalcetide 5 MG per 1 ML Injection	SY	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876137	etelcalcetide 5 MG/ML per 0.5 ML Injection	SY	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876127	etelcalcetide 5 MG/ML per 2 ML Injection	SY	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876132	Parsabiv 10 MG per 2 ML Injection	SY	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876138	Parsabiv 2.5 MG per 0.5 ML Injection	SY	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876136	Parsabiv 5 MG per 1 ML Injection	SY	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876138	Parsabiv 5 MG/ML per 0.5 ML Injection	SY	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876136	Parsabiv 5 MG/ML per 1 ML Injection	SY	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15
1876132	Parsabiv 5 MG/ML per 2 ML Injection	SY	cd270093-c6a8-4596-a4ab-e6aa0a2c8a0c	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55513-742-10	55513074210	10 VIAL, SINGLE-DOSE in 1 CARTON (55513-742-10) / 2 mL in 1 VIAL, SINGLE-DOSE (55513-742-01)	2017-04-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PARSABIV	Amgen, Inc \| Amgen Manufacturing Limited LLC \| Amgen Inc.	2026-03-08	HUMAN PRESCRIPTION DRUG LABEL	15