Tigecycline

Product NDC: 70121-1647
11-digit product format: 701211647
Labeler code: 70121
Product ID: 70121-1647_c21de58f-dcd0-46f7-a6d9-0ff5ba5863a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tigecycline
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Amneal Pharmaceuticals LLC
Application: NDA211158
Marketing category: NDA
Marketing start: 2018-01-31
Substance: TIGECYCLINE
Active strength: 50 mg/5mL
Pharmacologic classes: Tetracycline-class Antibacterial [EPC], Tetracyclines [CS]
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
N211158-001	TIGECYCLINE	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP		2018-08-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N211158-001	AP

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211158-001	9855335	2033-04-07		Drug product	2018-09-19

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	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS		2018-08-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211158-001	TIGECYCLINE	50MG/VIAL	POWDER / INTRAVENOUS	AP	2018-08-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N211158-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211158-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211158-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211158-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211158-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211158-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211158-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211158-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211158-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211158-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211158-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211158-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211158-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211158-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211158-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211158-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211158-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211158-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211158-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211158-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211158-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211158-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211158-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211158-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211158-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211158-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211158-001	AP	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211158-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211158-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211158-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211158-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211158-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211158-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211158-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211158-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211158-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211158-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211158-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211158-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211158-001	AP	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211158-001	9855335	2033-04-07	Drug product	2018-09-19	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tigecycline
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TIGECYCLINE	50 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
70JE2N95KR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
581531	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
8450bd15-2b06-4fc7-b302-9021312e3f0d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dd6d14ea-96ce-47d6-bb4d-e83a98d059a0	Product name	1	20181011
ce7f9e4b-57d2-4e93-9935-2aafa036a504	Product name	1	20180424
ae8ca335-9ee1-4a78-92e9-2334f46963a8	Product name	1	20170214
72b449d8-80ee-4105-8917-897614a9b02b	Product name	1	20150611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70121-1647-1	Tigecycline	5 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	5		19
70121-1647-7	Tigecycline	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70121-1647-1	EA - Each	70121-1647	d05ef98e-625c-45fb-b545-ee1b2ec5dc56	1	2019-09-05
70121-1647-7	EA - Each	70121-1647	092a9b7e-e4bc-4f55-ae46-99bf141b262b	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70121-1647	TIGECYCLINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC]	19	Current NDC, Legacy NDC, 2 package rows	20250403_8450bd15-2b06-4fc7-b302-9021312e3f0d.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
Tigecycline	TIGECYCLINE	Amneal Pharmaceuticals LLC	8450bd15-2b06-4fc7-b302-9021312e3f0d	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 211158 application number: NDA211158 ndc (product): 70121-1647

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
70JE2N95KR	TIGECYCLINE	220620-09-7	TIGECYCLINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
581531	tigecycline 50 MG Injection	PSN	8450bd15-2b06-4fc7-b302-9021312e3f0d	19
581531	tigecycline 50 MG Injection	SCD	8450bd15-2b06-4fc7-b302-9021312e3f0d	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70121-1647-1	70121164701	5 mL in 1 VIAL	5 ml					Historical
70121-1647-7	70121164707	10 VIAL in 1 CARTON (70121-1647-7) / 5 mL in 1 VIAL (70121-1647-1)	10 vial	2018-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tigecycline	Amneal Pharmaceuticals LLC \| Gland Pharma Limited	2024-12-17	HUMAN PRESCRIPTION DRUG LABEL	19