Prescription drug · ANDA

Tamsulosin Hydrochloride NDC 0615-8055

Tamsulosin hydrochloride .4 mg/1 · Capsule · Oral · NCS HealthCare of KY, LLC dba Vangard Labs

NDC codes

FDA NDC Directory
Product NDC (as listed)0615-8055Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00615-8055Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0615-8055-050061580550515 CAPSULE in 1 BLISTER PACK (0615-8055-05)Marketed from Apr 30, 2013
0615-8055-07006158055077 CAPSULE in 1 BLISTER PACK (0615-8055-07)Marketed from Sep 27, 2018
0615-8055-140061580551414 CAPSULE in 1 BLISTER PACK (0615-8055-14)Marketed from Aug 24, 2023
0615-8055-280061580552828 CAPSULE in 1 BLISTER PACK (0615-8055-28)Marketed from Apr 25, 2024
0615-8055-30006158055306 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8055-30) / 5 CAPSULE in 1 BLISTER PACKMarketed from Mar 28, 2019
0615-8055-390061580553930 CAPSULE in 1 BLISTER PACK (0615-8055-39)Marketed from Apr 30, 2013

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Tamsulosin Hydrochloride
Generic name (nonproprietary)
tamsulosin hydrochloride
Active ingredients
Tamsulosin hydrochloride — .4 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202433
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Antagonists (Mechanism)
Identifiers
Product ID 0615-8055_b5eec9b2-57b2-44f8-8117-3af64069e4d2SPL ID b5eec9b2-57b2-44f8-8117-3af64069e4d2SPL set ID 503d080c-9db3-434a-add6-c7d0e5a0ab2eRxCUI 863669UNII 11SV1951MR
Pharmacologic class
alpha-Adrenergic Blocker

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400615805505 followed by a unit qualifier and the quantity

Package 00615-8055-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [see Clinical Studies (14) ] . Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. Tamsulosin hydrochloride capsules are an alpha 1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia. (1) Tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202433

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 202433
ProductStrengthForm · routeLabelerProduct NDC
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralBryant Ranch Prepack71335-1784
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-4443
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralREMEDYREPACK INC.70518-2052
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralPreferred Pharmaceuticals, Inc.68788-7050
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-5118
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralA-S Medication Solutions50090-1846
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralBryant Ranch Prepack72162-2217
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralMajor Pharmaceuticals0904-7383
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralBryant Ranch Prepack72162-2509
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralAphena Pharma Solutions - Tennessee, LLC71610-835
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralProficient Rx LP63187-358
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.43063-947
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralProficient Rx LP63187-371
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralProficient Rx LP71205-688
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralA-S Medication Solutions50090-5553
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralRising Pharma Holdings, Inc.57237-014
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralRedpharm Drug67296-2220
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralNorthStar Rx LLC72603-115
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralDIRECT RX61919-703
Tamsulosin HydrochlorideTamsulosin hydrochloride .4 mg/1CapsuleOralDirect_Rx61919-703

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