Telmisartan and Amlodipine

Product NDC: 68180-199
Requested package NDC: 68180-199-12
11-digit product format: 681800199
Labeler code: 68180
Product ID: 68180-199_db056024-a5b4-4f2a-8fe0-8ee308cf5700
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Telmisartan and Amlodipine
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA201586
Marketing category: ANDA
Marketing start: 2014-01-08
Marketing end: 0000-00-00
Substance: TELMISARTAN; AMLODIPINE BESYLATE
Active strength: 80 mg/1; mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A201586-001	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;40MG	TABLET / ORAL	2014-01-08
A201586-002	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;40MG	TABLET / ORAL	2014-01-08
A201586-003	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;80MG	TABLET / ORAL	2014-01-08
A201586-004	TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;80MG	TABLET / ORAL	2014-01-08

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 5 · 172 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
2026-09-14 22:38:34	2026-08	A201586-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL		2014-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201586-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL		2014-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201586-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL		2014-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201586-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL		2014-01-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201586-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL		2014-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201586-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL		2014-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201586-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL		2014-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201586-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL		2014-01-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201586-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL		2014-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201586-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL		2014-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201586-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL		2014-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201586-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL		2014-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201586-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2014-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201586-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2014-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201586-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	AB	2014-01-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201586-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	AB	2014-01-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201586-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2014-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201586-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2014-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201586-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	AB	2014-01-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201586-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	AB	2014-01-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201586-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2014-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201586-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2014-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201586-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	AB	2014-01-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201586-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	AB	2014-01-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201586-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2014-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201586-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2014-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201586-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	AB	2014-01-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201586-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	AB	2014-01-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201586-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201586-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201586-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	AB	2014-01-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201586-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	AB	2014-01-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201586-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201586-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201586-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	AB	2014-01-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201586-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	AB	2014-01-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201586-001	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;40MG	TABLET / ORAL	AB	2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201586-002	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;40MG	TABLET / ORAL	AB	2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201586-003	TELMISARTAN AND AMLODIPINE	EQ 5MG BASE;80MG	TABLET / ORAL	AB	2014-01-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201586-004	TELMISARTAN AND AMLODIPINE	EQ 10MG BASE;80MG	TABLET / ORAL	AB	2014-01-08	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201586-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201586-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201586-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201586-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201586-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201586-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201586-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201586-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201586-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201586-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201586-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201586-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201586-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201586-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201586-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201586-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201586-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201586-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201586-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201586-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201586-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201586-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201586-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201586-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201586-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201586-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201586-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201586-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201586-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201586-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201586-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201586-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201586-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201586-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201586-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201586-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201586-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201586-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201586-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201586-004	AB	1	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
14c2c15b-f823-4ada-a40e-a440544294dc	Product name	1	20221207
a72887ef-d675-499f-af4b-78688f6855cd	Product name	1	20191002
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
a4484670-2869-6416-f6ff-03b1b3cbd1b0	Product name	2	20190415
4a27501f-a987-48a5-99b4-e983d4744d76	Product name	7	20181211
18600d07-613d-bf9c-2711-fe40c06f3393	Product name	5	20180703
796916df-49fa-d043-64a7-fee11194676c	Product name	9	20171130
bded1554-44de-900a-5297-403365d6d4b2	Product name	3	20170110
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1	Product name	1	20150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68180-199-06	Telmisartan and Amlodipine	30 in 1 BOTTLE	TABLET	30	10
68180-199-09	Telmisartan and Amlodipine	90 in 1 BOTTLE	TABLET	90	10
68180-199-12	Telmisartan and Amlodipine	10 in 1 BLISTER PACK	TABLET	10	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-199-06	EA - Each	68180-199	4e151bf3-e7d6-479e-9579-bc5690fadd52	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]	3
TELMISARTAN	ACTIVE INGREDIENT	U5SYW473RQ	TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]	3
AMLODIPINE	ACTIVE MOIETY	1J444QC288	TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]	3
TELMISARTAN	ACTIVE MOIETY	U5SYW473RQ	TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-199	TELMISARTAN AND AMLODIPINE TABLET [LUPIN PHARMACEUTICALS, INC.]	10	Legacy NDC, 3 package rows	20231216_a97fefa6-99e6-4eb7-9393-ab2252a2c7d8.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
Telmisartan and Amlodipine	TELMISARTAN AND AMLODIPINE	Lupin Pharmaceuticals, Inc.	a97fefa6-99e6-4eb7-9393-ab2252a2c7d8	2023-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201586 application number: ANDA201586 ndc (package): 68180-199-12 ndc (product): 68180-199 ndc11 (package): 68180019912

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U5SYW473RQ	TELMISARTAN	144701-48-4	TELMISARTAN
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
876514	telmisartan 40 MG / amLODIPine 10 MG Oral Tablet	PSN	a97fefa6-99e6-4eb7-9393-ab2252a2c7d8	10
876524	telmisartan 40 MG / amLODIPine 5 MG Oral Tablet	PSN	a97fefa6-99e6-4eb7-9393-ab2252a2c7d8	10
876519	telmisartan 80 MG / amLODIPine 10 MG Oral Tablet	PSN	a97fefa6-99e6-4eb7-9393-ab2252a2c7d8	10
876529	telmisartan 80 MG / amLODIPine 5 MG Oral Tablet	PSN	a97fefa6-99e6-4eb7-9393-ab2252a2c7d8	10
876514	amlodipine 10 MG / telmisartan 40 MG Oral Tablet	SCD	a97fefa6-99e6-4eb7-9393-ab2252a2c7d8	10
876519	amlodipine 10 MG / telmisartan 80 MG Oral Tablet	SCD	a97fefa6-99e6-4eb7-9393-ab2252a2c7d8	10
876524	amlodipine 5 MG / telmisartan 40 MG Oral Tablet	SCD	a97fefa6-99e6-4eb7-9393-ab2252a2c7d8	10
876529	amlodipine 5 MG / telmisartan 80 MG Oral Tablet	SCD	a97fefa6-99e6-4eb7-9393-ab2252a2c7d8	10
876514	amlodipine (as amlodipine besylate) 10 MG / telmisartan 40 MG Oral Tablet	SY	a97fefa6-99e6-4eb7-9393-ab2252a2c7d8	10
876519	amlodipine (as amlodipine besylate) 10 MG / telmisartan 80 MG Oral Tablet	SY	a97fefa6-99e6-4eb7-9393-ab2252a2c7d8	10
876524	amlodipine (as amlodipine besylate) 5 MG / telmisartan 40 MG Oral Tablet	SY	a97fefa6-99e6-4eb7-9393-ab2252a2c7d8	10
876529	amlodipine (as amlodipine besylate) 5 MG / telmisartan 80 MG Oral Tablet	SY	a97fefa6-99e6-4eb7-9393-ab2252a2c7d8	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-199-12	68180019912	10 TABLET in 1 BLISTER PACK (68180-199-12)	10 tablet	2014-01-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Telmisartan and Amlodipine	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2023-12-15	HUMAN PRESCRIPTION DRUG LABEL	10
Telmisartan and Amlodipine	AvKARE	2022-01-17	HUMAN PRESCRIPTION DRUG LABEL	4