Byetta

Product NDC: 0310-6524
11-digit product format: 003106524
Labeler code: 0310
Product ID: 0310-6524_7333a7dd-9449-4c61-b36d-c5d8d7cc239b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: exenatide
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: AstraZeneca Pharmaceuticals LP
Application: NDA021773
Marketing category: NDA
Marketing start: 2014-12-12
Marketing end: 2026-11-30
Substance: EXENATIDE
Active strength: 250 ug/mL
Pharmacologic classes: GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC exclude flag: No
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021773-001	BYETTA	EXENATIDE SYNTHETIC	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD	2005-04-28
N021773-002	BYETTA	EXENATIDE SYNTHETIC	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD	2005-04-28

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 3 · 84 observed 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	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD	2005-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD	2005-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD	2005-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD	2005-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD	2005-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD	2005-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD	2005-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD	2005-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2005-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2005-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2005-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2005-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2005-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2005-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2005-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS	AP	RLD, RS	2005-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021773-001	BYETTA	300MCG/1.2ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021773-002	BYETTA	600MCG/2.4ML (250MCG/ML)	INJECTABLE / SUBCUTANEOUS		RLD, RS	2005-04-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021773-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021773-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021773-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021773-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021773-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021773-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021773-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021773-002	AP	1	`2680178bc6a6…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021773-001	6872700	2020-01-14	U-654		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021773-001	6902744	2020-01-14		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021773-002	6872700	2020-01-14	U-654		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021773-002	6902744	2020-01-14		Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021773-001	6872700	2020-01-14	U-654		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021773-001	6902744	2020-01-14		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021773-002	6872700	2020-01-14	U-654		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021773-002	6902744	2020-01-14		Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021773-001	6872700	2020-01-14	U-654		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021773-001	6902744	2020-01-14		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021773-002	6872700	2020-01-14	U-654		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021773-002	6902744	2020-01-14		Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021773-001	6872700	2020-01-14	U-654		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021773-001	6902744	2020-01-14		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021773-002	6872700	2020-01-14	U-654		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021773-002	6902744	2020-01-14		Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021773-001	6872700	2020-01-14	U-654		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021773-001	6902744	2020-01-14		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021773-002	6872700	2020-01-14	U-654		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021773-002	6902744	2020-01-14		Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021773-001	6872700	2020-01-14	U-654		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021773-001	6902744	2020-01-14		Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021773-002	6872700	2020-01-14	U-654		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021773-002	6902744	2020-01-14		Drug product	`ea99ee380514…`

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
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021773-001	M-232	2024-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021773-002	M-232	2024-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021773-001	M-232	2024-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021773-002	M-232	2024-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021773-001	M-232	2024-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021773-002	M-232	2024-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021773-001	M-232	2024-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021773-002	M-232	2024-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021773-001	M-232	2024-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021773-002	M-232	2024-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021773-001	M-232	2024-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021773-002	M-232	2024-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021773-001	M-232	2024-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021773-002	M-232	2024-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021773-001	M-232	2024-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021773-002	M-232	2024-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021773-001	M-232	2024-11-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021773-002	M-232	2024-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021773-001	M-232	2024-11-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021773-002	M-232	2024-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021773-001	M-232	2024-11-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021773-002	M-232	2024-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021773-001	M-232	2024-11-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021773-002	M-232	2024-11-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021773-001	M-232	2024-11-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021773-002	M-232	2024-11-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021773-001	M-232	2024-11-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021773-002	M-232	2024-11-04	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021773-001	M-232	2024-11-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021773-002	M-232	2024-11-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021773-001	M-232	2024-11-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021773-002	M-232	2024-11-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021773-001	M-232	2024-11-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021773-002	M-232	2024-11-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021773-001	M-232	2024-11-04	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021773-002	M-232	2024-11-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021773-001	M-232	2024-11-04	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021773-002	M-232	2024-11-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021773-001	M-232	2024-11-04	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021773-002	M-232	2024-11-04	`a67488948f0b…`

Additional Listing Data#

Finished product: Yes
Brand name base: Byetta

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EXENATIDE	250 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9P1872D4OL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
847910	Internal RxNorm lookup
847913	Internal RxNorm lookup
847915	Internal RxNorm lookup
847917	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
53d03c03-ebf7-418d-88a8-533eabd2ee4f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
910a43af-bf3b-4a75-af76-a237c61fbc82	Product name	1	20250717
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
8f64a1da-980a-4c97-8c3f-c572643b48f9	Product name	1	20171212
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0310-6524-01	Byetta	2.4 mL in 1 CARTRIDGE	INJECTION	2.4		26
0310-6524-01	Byetta	1 in 1 CARTON	INJECTION	1		26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-6524-01	ML - Milliliter	0310-6524	86c1f4dd-656c-45d2-b966-638190a6b091	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
exenatide	ACTIVE INGREDIENT	9P1872D4OL	BYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]	2
exenatide	ACTIVE MOIETY	9P1872D4OL	BYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]	2
acetic acid	INACTIVE INGREDIENT	Q40Q9N063P	BYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]	2
mannitol	INACTIVE INGREDIENT	3OWL53L36A	BYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]	2
metacresol	INACTIVE INGREDIENT	GGO4Y809LO	BYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]	2
sodium acetate	INACTIVE INGREDIENT	4550K0SC9B	BYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]	2
water	INACTIVE INGREDIENT	059QF0KO0R	BYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0310-6524	BYETTA (EXENATIDE) INJECTION [ASTRAZENECA PHARMACEUTICALS LP]	24	Current NDC, Legacy NDC, 2 package rows	20241113_53d03c03-ebf7-418d-88a8-533eabd2ee4f.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
Byetta	EXENATIDE	AstraZeneca Pharmaceuticals LP	53d03c03-ebf7-418d-88a8-533eabd2ee4f	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021773 application number: NDA021773 ndc (product): 0310-6524

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9P1872D4OL	EXENATIDE	141758-74-9	EXENATIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
847913	Byetta 10 MCG, 250 MCG/ML in 2.4 mL Pen Injector	PSN	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847917	Byetta 5 MCG, 250 MCG/ML in 1.2 mL Pen Injector	PSN	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847910	exenatide 10 MCG, 250 MCG/ML in 2.4 mL Pen Injector	PSN	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847915	exenatide 5 MCG, 250 MCG/ML in 1.2 mL Pen Injector	PSN	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847917	60 ACTUAT exenatide 0.005 MG/ACTUAT Pen Injector [Byetta]	SBD	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847913	60 ACTUAT exenatide 0.01 MG/ACTUAT Pen Injector [Byetta]	SBD	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847915	60 ACTUAT exenatide 0.005 MG/ACTUAT Pen Injector	SCD	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847910	60 ACTUAT exenatide 0.01 MG/ACTUAT Pen Injector	SCD	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847917	60 ACTUAT Byetta 0.005 MG/ACTUAT Pen Injector	SY	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847913	60 ACTUAT Byetta 0.01 MG/ACTUAT Pen Injector	SY	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847913	Byetta 10 MCG/ACTUAT Pen Injector, 60 ACTUAT	SY	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847917	Byetta 250 MCG/ML Pen Injector, 1.2 ML	SY	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847913	Byetta 250 MCG/ML Pen Injector, 2.4 ML	SY	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847917	Byetta 5 MCG/ACTUAT Pen Injector, 60 ACTUAT	SY	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847910	exenatide 10 MCG/ACTUAT Pen Injector, 60 ACTUAT	SY	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847915	exenatide 250 MCG/ML Pen Injector, 1.2 ML	SY	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847910	exenatide 250 MCG/ML Pen Injector, 2.4 ML	SY	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26
847915	exenatide 5 MCG/ACTUAT Pen Injector, 60 ACTUAT	SY	53d03c03-ebf7-418d-88a8-533eabd2ee4f	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0310-6524-01	00310652401	1 CARTRIDGE in 1 CARTON (0310-6524-01) / 2.4 mL in 1 CARTRIDGE	1 cartridge	2014-12-12	2026-11-30	No	No	Current